XTX202 in Patients With Advanced Solid Tumors | NCT05052268 | Trialant
NCT05052268
Sponsor
Xilio Development, Inc.
Status
Completed
Last Update Posted
May 28, 2026Actual
Enrollment
95Actual
Phase
Phase 1Phase 2
Conditions
Advanced Solid Tumor
Interventions
XTX202
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05052268
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
XTX202-01/02-001
Secondary IDs
Not provided
Brief Title
XTX202 in Patients With Advanced Solid Tumors
Official Title
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients With Advanced Solid Tumors
Acronym
Not provided
Organization
Xilio Development, Inc.INDUSTRY
Status Module
Record Verification Date
Mar 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 18, 2022Actual
Primary Completion Date
Mar 22, 2025Actual
Completion Date
Mar 25, 2025Actual
First Submitted Date
Aug 23, 2021
First Submission Date that Met QC Criteria
Sep 10, 2021
First Posted Date
Sep 22, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Mar 20, 2026
Results First Submitted that Met QC Criteria
Apr 30, 2026
Results First Posted Date
May 28, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 30, 2026
Last Update Posted Date
May 28, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Xilio Development, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors
Detailed Description
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, and efficacy of XTX202, an engineered IL-2 prodrug with its activity masked, as monotherapy in patients with advanced solid tumors.
Phase 1 Part 1a will examine XTX202 monotherapy in an accelerated and standard 3+3 dose-escalation design. Based on the results of Part 1a, Part 1b will be initiated to further examine XTX202 in patients with select advanced solid tumors and to further characterize XTX202.
Based on results of Phase 1 patients with select advanced solid tumors will be enrolled in Phase 2.
Conditions Module
Conditions
Advanced Solid Tumor
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
95Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion
Experimental
Part 1A Dose Escalation of XTX202 administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 doses (RP2Ds).
Part 1B Evaluation of XTX202 in patients with selected advanced solid tumors to further characterize the pharmacodynamic profile of XTX202
Drug: XTX202
Phase 2 XTX202 Dose Expansion
Experimental
Part 2A will enroll patients with metastatic renal cell carcinoma who have progressed following standard-of-care treatment.
Part 2B will enroll patients with melanoma who have progressed following standard-of-care treatment.
Drug: XTX202
Interventions
Name
Type
Description
Arm Group Labels
Other Names
XTX202
Drug
XTX202 Monotherapy
Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion
Phase 2 XTX202 Dose Expansion
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only)
All participants in Phase 1 Part 1A (Dose Escalation) who received at least 1 dose of XTX202 and experienced a DLT. DLTs were defined as the following:
Any treatment-related Grade ≥ 3 toxicity
Any Grade febrile neutropenia
The following nonhematologic exceptions:
Grade 3 nausea or vomiting lasting < 3 days
Grade 3 fatigue lasting < 7 days
Any treatment-related toxicity that resulted in a treatment delay of ≥ 7 days
Cycle 1 day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (each cycle is 21 days)
Incidence of Treatment-emergent Adverse Events (Phase 1 Only)
Treatment-emergent adverse event (TEAE) is defined as any adverse event that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. Adverse events are graded using the NCI CTCAE version 5.0.
Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response is based on Investigator assessment according to RECIST v1.1.
In the analysis set used for ORR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Biochemistry
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response will be based on Investigator's assessment according to RECIST v1.1.
Up to 24 months
Duration of Response (DOR) (Phase 2 Only)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Disease Criteria
Phase 1, Part 1a: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available
Phase 1, Part 1b: Histologically or cytologically confirmed solid tumor malignancy with one of the following tumor histologies: RCC of clear cell histology only, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer. Those patients who previously received immunotherapy must have derived benefit from this treatment. Additionally, patients with any of the above histologies in an advanced setting who plan to undergo debulking surgery or oligometastasectomy may be eligible to receive 2 cycles of XTX202 treatment in a "window of opportunity" subcohort".
Phase 2, Part 2a: Patients with metastatic RCC who have previously been treated with an anti-PD-1 and a TKI, per local and institutional SOC. Patients must have progressed on treatment with an anti-PD-1 mAb administered either as monotherapy or in combination with other therapies
Phase 2, Part 2b: Patients with unresectable or metastatic melanoma who have previously been treated with at least 1 prior line of therapy in the recurrent or metastatic setting. Prior therapy must have included an anti-PD-1 alone or in combination per local and institutional standard of care, and patient must have progressed on checkpoint inhibitor therapy. Patients with BRAF V600-activating mutation must have previously received targeted therapy per local and institutional standard of care.
ECOG performance status of 0 or 1
Adequate organ function
Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment.
Exclusion Criteria:
Received prior treatment with IL-2 therapy
History of clinically significant pulmonary disease
History of clinically significant cardiovascular disease
Has a diagnosis of immunodeficiency
Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs
Has an active infection requiring systemic therapy within 4 weeks prior to study treatment
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UC San Diego Moores Cancer Center
La Jolla
California
92093
United States
Norris Comprehensive Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
36 of the 39 subjects discontinued the study for "Other reason", this other reason was due to the discontinuation of the 90-Day Safety Follow up and Survival Visits
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 7, 2024
Feb 27, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Hematology
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Thyroid Function
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Coagulation
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. Missing = number of patients with missing baseline and/or post baseline laboratory value
Up to 24 months
Duration of response is defined as time from first documentation of a subsequently confirmed objective response (CR or PR) to the date of the first documentation of radiographic disease progression according to Investigator assessment by RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date.
Up to 24 months
Disease Control Rate (Phase 2 Only)
Disease Control Rate (DCR) is defined as percentage of participants with confirmed BOR of CR, PR or SD (minimum duration of 6 weeks) according to RECIST v1.1, after the first dose of study treatment.
In the analysis set used for DCR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Up to 24 months
Overall Survival (OS) (Phase 2 Only)
OS is defined as the time from first administration of study treatment to death due to any cause. For participants without a record of death, OS will be censored at the date they were last known alive.
In the analysis set used for OS, participants are assigned to a treatment group based on the initial dose received.. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
Up to 24 months
Progression-free Survival (PFS) (Phase 2 Only)
PFS is defined as the time from first administration of study treatment until first documentation of radiographic PD according to RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date.
In the analysis set used for PFS, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
Up to 24 months
Incidence of Treatment-emergent Adverse Events (Phase 2 Only)
Treatment-emergent adverse event is defined as any adverse event (AE) that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. AEs are graded using the NCI CTCAE version 5.0.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Hematology
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Biochemistry
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Thyroid Function
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Coagulation
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Up to 24 months
Plasma Concentrations of Total XTX202
Plasma Concentration of Total XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1
Plasma Concentrations of Intact XTX202
Plasma Concentration of Intact XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1
Total XTX202 Plasma Trough Concentration
Plasma Trough Concentration of Total XTX202 Following Multiple IV Administrations of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
From Cycle 1 to up to Cycle 18 (21 days per cycle)
Intact XTX202 Plasma Trough Concentration
Plasma Trough Concentration of Intact XTX202 Following Multiple IV Administrations of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
from Cycle 1 to up to Cycle 18 (21 days per cycle)
Maximum Observed Plasma Concentration (Cmax) of Total XTX202
Cmax following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Maximum Observed Plasma Concentration (Cmax) of Intact XTX202
Cmax following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Time of Maximum Observed Concentration (Tmax) of Total XTX202
Time of maximum observed concentration (Tmax) of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Time of Maximum Observed Concentration (Tmax) of Intact XTX202
Time of maximum observed concentration (Tmax) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Total XTX202
Area under the curve (AUC)of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Intact XTX202
Area under the curve (AUC) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Half-life (T1/2) of Total XTX202
Half-life (T1/2) of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Half-life (T1/2) of Intact XTX202
Half-life (T1/2) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Systemic Clearance (CL) of Total XTX202
Systemic clearance (CL) of Total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Systemic Clearance (CL) of Intact XTX202
Systemic clearance (CL) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Volume of Distribution (Vd) of Total XTX202
Volume of distribution (Vd) of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Volume of Distribution (Vd) of Intact XTX202
Volume of distribution (Vd) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Antidrug Antibody (ADA) Occurrence and Titer in Serum (Phase 1 Only)
Overall ADA Incidence Following a Single IV Administration of XTX202
In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
from Cycle 1 Day 1 to up to 24 months
Incidence and Persistence of ADAs (Including Neutralizing ADAs) and Titers (Phase 2 Only)
Overall ADA Incidence Following a Single IV Administration of XTX202.
In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
From Cycle 1 Day 1 to up to 24 months
Los Angeles
California
90033
United States
University of California Los Angeles
Los Angeles
California
90095
United States
Hoag Memorial Hospital Presbyterian- Newport Beach
Newport Beach
California
92663
United States
Georgetown University Medical Center
Washington D.C.
District of Columbia
20007
United States
Moffitt Cancer Center
Tampa
Florida
33612
United States
University of Iowa Hospitals and Clinics
Iowa City
Iowa
52242
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
HealthPartners Cancer Center at Regions Hospital
Saint Paul
Minnesota
55101
United States
Atlantic Health System/Morristown Medical Center
Morristown
New Jersey
07960
United States
Rutgers Cancer Institute of NJ
New Brunswick
New Jersey
08903
United States
Carolina BioOncology Institute
Huntersville
North Carolina
28078
United States
The Ohio State University Wexner Medical Center James Cancer Hospital and Solove Research Institute
Columbus
Ohio
43210
United States
UPMC Hillman Cancer Center Pavilion
Pittsburgh
Pennsylvania
15213
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
FG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0038 subjects
FG00413 subjects
FG0058 subjects
FG00613 subjects
FG0071 subjects
FG0082 subjects
FG0095 subjects
FG0101 subjects
FG0112 subjects
FG01215 subjects
FG0135 subjects
FG01415 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0038 subjects
FG00413 subjects
FG0058 subjects
FG00613 subjects
FG0071 subjects
FG0082 subjects
FG0095 subjects
FG0101 subjects
FG0112 subjects
FG01215 subjects
FG0135 subjects
FG01415 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0036 subjects
FG00411 subjects
FG0056 subjects
FG0065 subjects
FG0070 subjects
FG0082 subjects
FG0092 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0146 subjects
Investigator Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal of Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other Reason
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
All subjects who received any amount of XTX202, with the treatment group based on the highest DL received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
BG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0013
BG0023
BG0038
BG00413
BG0058
BG00613
BG0071
BG0082
BG0095
BG0101
BG0112
BG01215
BG0135
BG01415
BG01595
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00067± 0
BG00169.7± 16.2
BG00261.7± 14.64
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<65
BG0000
BG0011
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only)
All participants in Phase 1 Part 1A (Dose Escalation) who received at least 1 dose of XTX202 and experienced a DLT. DLTs were defined as the following:
Any treatment-related Grade ≥ 3 toxicity
Any Grade febrile neutropenia
The following nonhematologic exceptions:
Grade 3 nausea or vomiting lasting < 3 days
Grade 3 fatigue lasting < 7 days
Any treatment-related toxicity that resulted in a treatment delay of ≥ 7 days
Posted
Count of Participants
Participants
Cycle 1 day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (each cycle is 21 days)
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Incidence of Treatment-emergent Adverse Events (Phase 1 Only)
Treatment-emergent adverse event (TEAE) is defined as any adverse event that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. Adverse events are graded using the NCI CTCAE version 5.0.
All participants who received XTX202 in Phase 1 Part 1A and Part 1B.
Posted
Number
Number of participants with TEAE
Up to 24 months
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response is based on Investigator assessment according to RECIST v1.1.
In the analysis set used for ORR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
All participants in Phase 2 Part 2A and Part 2B with measurable disease at baseline who received XTX202 and had at least 1 post-Baseline response assessment or discontinued treatment due to disease progression (including death caused by disease progression) prior to the first efficacy evaluation were included in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Primary
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Biochemistry
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
All participants who received XTX202 in Phase 1 Part 1A and Part 1B with both baseline and at least one post-baseline result.
Posted
Count of Participants
Participants
Up to 24 months
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Primary
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Hematology
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
All participants who received XTX202 in Phase 1 Part 1A and Part 1B with both baseline and at least one post-baseline result.
Posted
Count of Participants
Participants
up to 24 months
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Primary
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Thyroid Function
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
All participants who received XTX202 in Phase 1 Part 1A and Part 1B with both baseline and at least one post-baseline result.
Posted
Count of Participants
Participants
Up to 24 months
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Primary
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Coagulation
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. Missing = number of patients with missing baseline and/or post baseline laboratory value
All participants who received XTX202 in Phase 1 Part 1A and Part 1B with both baseline and at least one post-baseline result.
Posted
Count of Participants
Participants
Up to 24 months
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response will be based on Investigator's assessment according to RECIST v1.1.
All subjects in Phase 1 Part 1A and Part 1B with measurable disease at baseline who received XTX202 and had at least 1 post-Baseline response assessment or discontinued treatment due to disease progression (including death caused by disease progression) prior to the first efficacy evaluation.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 24 months
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Duration of Response (DOR) (Phase 2 Only)
Duration of response is defined as time from first documentation of a subsequently confirmed objective response (CR or PR) to the date of the first documentation of radiographic disease progression according to Investigator assessment by RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date.
All participants in Phase 2 Part 2A and Part 2B with measurable disease at baseline who received XTX202 and had at least 1 post-Baseline response assessment or discontinued treatment due to disease progression (including death caused by disease progression) prior to the first efficacy evaluation and had a confirmed objective response (CR or PR).
Posted
Median
95% Confidence Interval
Days
Up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
Secondary
Disease Control Rate (Phase 2 Only)
Disease Control Rate (DCR) is defined as percentage of participants with confirmed BOR of CR, PR or SD (minimum duration of 6 weeks) according to RECIST v1.1, after the first dose of study treatment.
In the analysis set used for DCR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
All participants in Phase 2 Part 2A and Part 2B with measurable disease at baseline who received XTX202 and had at least 1 post-Baseline response assessment or discontinued treatment due to disease progression (including death caused by disease progression) prior to the first efficacy evaluation were included in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Overall Survival (OS) (Phase 2 Only)
OS is defined as the time from first administration of study treatment to death due to any cause. For participants without a record of death, OS will be censored at the date they were last known alive.
In the analysis set used for OS, participants are assigned to a treatment group based on the initial dose received.. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
All participants who received XTX202 in Phase 2 Part 2A and Part 2B were included in the analysis set
Posted
Median
95% Confidence Interval
months
Up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
Secondary
Progression-free Survival (PFS) (Phase 2 Only)
PFS is defined as the time from first administration of study treatment until first documentation of radiographic PD according to RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date.
In the analysis set used for PFS, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
All participants who received XTX202 in Phase 2 Part 2A and Part 2B were included in the analysis set.
Posted
Median
97.5% Confidence Interval
months
Up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Incidence of Treatment-emergent Adverse Events (Phase 2 Only)
Treatment-emergent adverse event is defined as any adverse event (AE) that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. AEs are graded using the NCI CTCAE version 5.0.
All participants who received XTX202 in Phase 2 Part 2A and Part 2B.
Posted
Number
Number of participants with TEAE
Up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
Secondary
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Hematology
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
All participants who received XTX202 in Phase 2 Part 2A and Part 2B with both baseline and at least one post-baseline result.
Posted
Count of Participants
Participants
Up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Biochemistry
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
All participants who received XTX202 in Phase 2 Part 2A and Part 2B with both baseline and at least one post-baseline result.
Posted
Count of Participants
Participants
Up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Thyroid Function
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
All participants who received XTX202 in Phase 2 Part 2A and Part 2B with both baseline and at least one post-baseline result.
Posted
Count of Participants
Participants
Up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Coagulation
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
All participants who received XTX202 in Phase 2 Part 2A and Part 2B with both baseline and at least one post-baseline result.
Posted
Count of Participants
Participants
Up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Plasma Concentrations of Total XTX202
Plasma Concentration of Total XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results.
Posted
Mean
Standard Deviation
ng/mL
0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Plasma Concentrations of Intact XTX202
Plasma Concentration of Intact XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results.
Posted
Mean
Standard Deviation
ng/mL
0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Total XTX202 Plasma Trough Concentration
Plasma Trough Concentration of Total XTX202 Following Multiple IV Administrations of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results.
Posted
Mean
Standard Deviation
ng/mL
From Cycle 1 to up to Cycle 18 (21 days per cycle)
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Intact XTX202 Plasma Trough Concentration
Plasma Trough Concentration of Intact XTX202 Following Multiple IV Administrations of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results.
Posted
Mean
Standard Deviation
ng/mL
from Cycle 1 to up to Cycle 18 (21 days per cycle)
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Maximum Observed Plasma Concentration (Cmax) of Total XTX202
Cmax following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results.
Posted
Mean
Standard Deviation
ng/mL
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Maximum Observed Plasma Concentration (Cmax) of Intact XTX202
Cmax following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results.
Posted
Mean
Standard Deviation
ng/mL
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Time of Maximum Observed Concentration (Tmax) of Total XTX202
Time of maximum observed concentration (Tmax) of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results. Note: In Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg Arm, Tmax value for Cycle 1 was reported based on measured concentration at collection timepoint scheduled immediately prior to Cycle 2 dose, however this collection timepoint may have been taken following the second dose
Posted
Mean
Standard Deviation
h
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
Secondary
Time of Maximum Observed Concentration (Tmax) of Intact XTX202
Time of maximum observed concentration (Tmax) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results. Note: In Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg Arm, Tmax value for Cycle 1 was reported based on measured concentration at collection timepoint scheduled immediately prior to Cycle 2 dose, however this collection timepoint may have been taken following the second dose.
Posted
Mean
Standard Deviation
h
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
Secondary
Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Total XTX202
Area under the curve (AUC)of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results
Posted
Mean
Standard Deviation
h*ng/mL
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Intact XTX202
Area under the curve (AUC) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results
Posted
Mean
Standard Deviation
h*ng/mL
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Half-life (T1/2) of Total XTX202
Half-life (T1/2) of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results
Posted
Mean
Standard Deviation
h
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Half-life (T1/2) of Intact XTX202
Half-life (T1/2) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results
Posted
Mean
Standard Deviation
h
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Systemic Clearance (CL) of Total XTX202
Systemic clearance (CL) of Total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results.
Posted
Mean
Standard Deviation
L/h
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Systemic Clearance (CL) of Intact XTX202
Systemic clearance (CL) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results.
Posted
Mean
Standard Deviation
L/h
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Volume of Distribution (Vd) of Total XTX202
Volume of distribution (Vd) of total XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results.
Posted
Mean
Standard Deviation
L
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Volume of Distribution (Vd) of Intact XTX202
Volume of distribution (Vd) of intact XTX202 following a single IV infusion of XTX202.
In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants received at least one dose of XTX202 and had at least 1 post dose measurement of XTX202 without protocol deviations or events affecting the validity of the PK results.
Posted
Mean
Standard Deviation
L
up to 21 days following a single IV infusion of XTX202 on Cycle 1
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Secondary
Antidrug Antibody (ADA) Occurrence and Titer in Serum (Phase 1 Only)
Overall ADA Incidence Following a Single IV Administration of XTX202
In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants who received at least one dose of XTX202 and had at least one post baseline blood sample collected to assess immunogenicity with reportable result.
Posted
Count of Participants
Participants
from Cycle 1 Day 1 to up to 24 months
ID
Title
Description
OG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Secondary
Incidence and Persistence of ADAs (Including Neutralizing ADAs) and Titers (Phase 2 Only)
Overall ADA Incidence Following a Single IV Administration of XTX202.
In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received.
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Participants who received at least one dose of XTX202 and had at least one post baseline blood sample collected to assess immunogenicity with reportable result.
Posted
Count of Participants
Participants
From Cycle 1 Day 1 to up to 24 months
ID
Title
Description
OG000
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG001
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
Time Frame
Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 24 months). Treatment-emergent related SAEs and Other related AEs were assessed from first dose to 90 days post last dose (up to approximately 24 months).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1 Part 1A, Dose Escalation- XTX202 0.27 mg/kg
XTX202 0.27 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
1
1
0
1
1
1
EG001
Phase 1 Part 1A, Dose Escalation- XTX202 0.38 mg/kg
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
2
3
0
3
1
3
EG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
3
3
0
3
2
3
EG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
6
8
0
8
6
8
EG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
11
13
0
13
10
13
EG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
6
8
0
8
7
8
EG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
5
13
4
13
12
13
EG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
0
1
0
1
0
1
EG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
2
2
0
2
2
2
EG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
2
5
0
5
3
5
EG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
0
1
0
1
1
1
EG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
0
2
0
2
2
2
EG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
0
15
6
15
15
15
EG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
1
5
2
5
5
5
EG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
6
15
2
15
14
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected8 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected13 at risk
EG0070 affected1 at risk
EG0080 affected2 at risk
EG0090 affected5 at risk
EG0100 affected1 at risk
EG0110 affected2 at risk
EG0120 affected15 at risk
EG0130 affected5 at risk
EG0140 affected15 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Polyradiculoneuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Immune system disorder
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0033 affected8 at risk
EG0043 affected13 at risk
EG0053 affected8 at risk
EG0063 affected13 at risk
EG0070 affected1 at risk
EG0081 affected2 at risk
EG0092 affected5 at risk
EG0101 affected1 at risk
EG0110 affected2 at risk
EG0127 affected15 at risk
EG0132 affected5 at risk
EG0148 affected15 at risk
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood lactic acid increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemoglobin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Polyradiculoneuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Immune system disorder
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Glaucoma
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphocyte morphology abnormal
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Immune-mediated arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Subcorneal pustular dermatosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0038
OG00413
OG0058
OG00613
OG0071
OG0082
OG0095
OG0101
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0023
OG0038
OG00413
OG0058
OG00613
OG0071
OG0082
OG0095
OG0101
OG002
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0002
OG00114
OG0026
OG00313
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 84.2)
OG0010(0.0 to 23.2)
OG00216.7(0.4 to 64.1)
OG0030(0.0 to 24.7)
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0038
OG00413
OG0058
OG00613
OG0071
OG0082
OG0095
OG0101
Title
Denominators
Categories
Alanine Aminotransferase increased - Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
OG0062
OG0070
OG0080
OG0090
OG0100
Alanine Aminotransferase increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin decreased (Hypoalbuminemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin decreased (Hypoalbuminemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alkaline Phosphatase increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alkaline Phosphatase increased - Garde 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Aspartate Aminotransferase increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Aspartate Aminotransferase increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood Bilirubin increased - Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
Blood Bilirubin increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium decreased (Hypocalcemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium decreased (Hypocalcemia) - Grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Calcium increased (Hypercalcemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium increased (Hypercalcemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose decreased (Hypoglycemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose decreased (Hypoglycemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Magnesium decreased (Hypomagnesemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Magnesium decreased (Hypomagnesemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Magnesium increased (Hypermagnesemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Magnesium increased (Hypermagnesemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium decreased (Hypokalemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium decreased (Hypokalemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium increased (Hyperkalemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium increased (Hyperkalemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serum Amylase increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serum Amylase increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium decreased (Hyponatremia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium decreased (Hyponatremia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium increased (Hypernatremia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium increased (Hypernatremia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0038
OG00413
OG0058
OG00613
OG0071
OG0082
OG0095
OG0101
Title
Denominators
Categories
Anemia (Hemoglobin decreased) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0043
OG0051
OG0064
OG0070
OG0080
OG0090
OG0100
Anemia (Hemoglobin decreased) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocyte count decreased - Grade 3
Title
Measurements
OG0000
OG0012
OG0020
OG003
Lymphocyte count decreased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocyte count increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocyte count increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophil count decreased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophil count decreased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets count decreased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets count decreased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
White Blood Cells decreased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
White Blood Cells decreased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0038
OG00413
OG0058
OG00613
OG0071
OG0082
OG0095
OG0101
Title
Denominators
Categories
Thyrotropin (mIU/L)
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0038
ParticipantsOG00413
ParticipantsOG0058
ParticipantsOG00613
ParticipantsOG0071
ParticipantsOG0082
ParticipantsOG0095
ParticipantsOG0101
Title
Measurements
Low (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG003
Thyroxine, Free (pmol/L)
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0038
Triiodothyronine (nmol/L)
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0038
Triiodothyronine, Free (pmol/L)
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0038
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0038
OG00413
OG0058
OG00613
OG0071
OG0082
OG0095
OG0101
Title
Denominators
Categories
Activated Partial Thromboplastin Time (sec)
Title
Measurements
Low (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Low (at baseline) to Normal (at post baseline)
OG0000
OG0010
OG0020
OG0030
OG004
Low (at baseline) to High (at post baseline)
OG0000
OG0010
OG0020
OG0030
OG004
Normal (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG0030
OG004
Normal (at baseline) to Normal (at post baseline)
OG0001
OG0011
OG0020
OG0031
OG004
Normal (at baseline) to High (at post baseline)
OG0000
OG0010
OG0020
OG0032
OG004
High (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG0030
OG004
High (at baseline) to Normal (at post baseline)
OG0000
OG0010
OG0021
OG0030
OG004
High (at baseline) to High (at post baseline)
OG0000
OG0010
OG0021
OG0032
OG004
Missing
OG0000
OG0012
OG0021
OG0033
OG004
Partial Thromboplastin Time (sec)
Title
Measurements
Low (at baseline) to Low (at post baseline)
OG0000
OG0012
OG0023
OG003
Prothrombin Intl. Normalized Ratio
Title
Measurements
Low (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG003
Prothrombin Time (sec)
Title
Measurements
Low (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG003
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
Units
Counts
Participants
OG0001
OG0013
OG0024
OG0038
OG00411
OG0057
OG00611
OG0071
OG0082
OG0096
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 97.5)
OG0010(0.0 to 70.8)
OG0020(0.0 to 60.2)
OG0030(0.0 to 36.9)
OG0040(0.0 to 28.5)
OG0050(0.0 to 41.0)
OG0060(0.0 to 28.5)
OG0070(0.0 to 97.5)
OG0080(0.0 to 84.2)
OG0090(0.0 to 45.9)
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0030
Title
Denominators
Categories
Title
Measurements
OG002NA(NA to NA)Median DOR and 95% confidence interval could not be determined because the single participant with PR remained in PR until the End-of-Treatment visit scan
OG002
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0002
OG00114
OG0026
OG00313
Title
Denominators
Categories
Title
Measurements
OG000100(15.8 to 100.0)
OG00150(23.0 to 77.0)
OG00250(11.8 to 88.2)
OG00353.8(25.1 to 80.8)
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0002
OG00115
OG0026
OG00314
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median OS was not reached. 95% Confidence Interval not evaluable due to insufficient number of participants with events.
OG001NA(NA to NA)Median OS was not reached. 95% Confidence Interval not evaluable due to insufficient number of participants with events.
OG002NA(6.1 to NA)Median OS was not reached. Upper limit of 95% Confidence Interval not evaluable due to insufficient number of participants with events.
OG003NA(3.9 to NA)Median OS was not reached. Upper limit of 95% Confidence Interval not evaluable due to insufficient number of participants with events.
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0002
OG00115
OG0026
OG00314
Title
Denominators
Categories
Title
Measurements
OG0004.1(4.0 to NA)"Upper Limit 95% Confidence Interval not evaluable due to insufficient number of participants with events"
OG0014.1(2.0 to 8.4)
OG0023.1(2.1 to NA)"Upper Limit 95% Confidence Interval not evaluable due to insufficient number of participants with events"
OG0032.7(1.0 to 4.1)
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0002
OG00115
OG0025
OG00315
Title
Denominators
Categories
Title
Measurements
OG0002
OG00115
OG0025
OG00315
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0002
OG00115
OG0025
OG00315
Title
Denominators
Categories
Anemia (Hemoglobin decreased) - Grade 3
Title
Measurements
OG0000
OG0011
OG0021
OG0031
Anemia (Hemoglobin decreased) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocyte count decreased - Grade 3
Title
Measurements
OG0001
OG0017
OG0021
OG003
Lymphocyte count decreased - Grade 4
Title
Measurements
OG0000
OG0010
OG0021
OG003
Lymphocyte count increased - Grade 3
Title
Measurements
OG0000
OG0012
OG0020
OG003
Lymphocyte count increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophil count decreased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophil count decreased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets count decreased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets count decreased - Grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
White Blood Cells decreased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
White Blood Cells decreased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0002
OG00115
OG0025
OG00315
Title
Denominators
Categories
Alanine Aminotransferase increased - Grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG0030
Alanine Aminotransferase increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin decreased (Hypoalbuminemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin decreased (Hypoalbuminemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alkaline Phosphatase increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Alkaline Phosphatase increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Aspartate Aminotransferase increased - Grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
Aspartate Aminotransferase increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood Bilirubin increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood Bilirubin increased- Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium decreased (Hypocalcemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium decreased (Hypocalcemia) - Grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Calcium increased (Hypercalcemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium increased (Hypercalcemia) - Grade 4
Title
Measurements
OG0000
OG0012
OG0020
OG003
Creatinine increased - Grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
Creatinine increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose decreased (Hypoglycemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Glucose decreased (Hypoglycemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Magnesium decreased (Hypomagnesemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Magnesium decreased (Hypomagnesemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Magnesium increased (Hypermagnesemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Magnesium increased (Hypermagnesemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium decreased (Hypokalemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Potassium decreased (Hypokalemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium increased (Hyperkalemia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium increased (Hyperkalemia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serum Amylase increased - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serum Amylase increased - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium decreased (Hyponatremia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium decreased (Hyponatremia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium increased (Hypernatremia) - Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium increased (Hypernatremia) - Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0002
OG00115
OG0025
OG00315
Title
Denominators
Categories
Thyrotropin (mIU/L)
Title
Measurements
Low (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG0030
Low (at baseline) to Normal (at post baseline)
OG0001
OG0010
OG0020
OG0030
Low (at baseline) to High (at post baseline)
OG0000
OG0011
OG0021
OG0030
Normal (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG0030
Normal (at baseline) to Normal (at post baseline)
OG0000
OG0014
OG0022
OG0037
Normal (at baseline) to High (at post baseline)
OG0000
OG0014
OG0021
OG0033
High (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG0030
High (at baseline) to Normal (at post baseline)
OG0001
OG0012
OG0021
OG0030
High (at baseline) to High (at post baseline)
OG0000
OG0012
OG0020
OG0032
Missing
OG0000
OG0012
OG0020
OG0033
Thyroxine, Free (pmol/L)
Title
Measurements
Low (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG003
Triiodothyronine (nmol/L)
Title
Measurements
Low (at baseline) to Low (at post baseline)
OG0000
OG0010
OG0020
OG003
Triiodothyronine, Free (pmol/L)
Title
Measurements
Low (at baseline) to Low (at post baseline)
OG0001
OG0015
OG0020
OG003
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0002
OG00115
OG0025
OG00315
Title
Denominators
Categories
Activated Partial Thromboplastin Time (sec)
Title
Measurements
Low (at baseline) to Low (post baseline)
OG0000
OG0010
OG0020
OG0030
Low (at baseline) to Normal (post baseline)
OG0000
OG0010
OG0020
OG0030
Low (at baseline) to High (post baseline)
OG0000
OG0010
OG0020
OG0030
Normal (at baseline) to Low (post baseline)
OG0000
OG0011
OG0020
OG0030
Normal (at baseline) to Normal (post baseline)
OG0000
OG0014
OG0022
OG0031
Normal (at baseline) to High (post baseline)
OG0001
OG0011
OG0020
OG0031
High (at baseline) to Low (post baseline)
OG0000
OG0010
OG0020
OG0030
High (at baseline) to Normal (post baseline)
OG0001
OG0012
OG0020
OG0030
High (at baseline) to High (post baseline)
OG0000
OG0013
OG0020
OG0030
Missing
OG0000
OG0014
OG0023
OG00313
Partial Thromboplastin Time (sec)
Title
Measurements
Low (at baseline) to Low (post baseline)
OG0000
OG0014
OG0023
OG003
Prothrombin Intl. Normalized Ratio
Title
Measurements
Low (at baseline) to Low (post baseline)
OG0000
OG0010
OG0020
OG003
Prothrombin Time (sec)
Title
Measurements
Low (at baseline) to Low (post baseline)
OG0000
OG0010
OG0020
OG003
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0038
OG00411
OG0057
OG00612
OG0071
OG0082
OG0096
OG0100
OG0112
OG0125
OG0136
OG0147
Title
Denominators
Categories
0.00 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0038
ParticipantsOG00410
ParticipantsOG0057
ParticipantsOG00612
ParticipantsOG0071
ParticipantsOG0082
ParticipantsOG0096
ParticipantsOG0100
ParticipantsOG0112
ParticipantsOG0125
ParticipantsOG0136
ParticipantsOG0147
Title
Measurements
OG000NA± 0Below the level of detection
OG001NA± 0Below the level of detection
OG0020± 0
OG003
0.0167 hours
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0035
0.250 hours
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0037
0.500 hours
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0037
1.50 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0038
3.00 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0038
24.0 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0038
72.0 hours
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0037
144 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0038
312 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0037
504 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0024
OG0039
OG00411
OG0057
OG00612
OG0071
OG0082
OG0096
OG0100
OG0112
OG0125
OG0136
OG0147
Title
Denominators
Categories
0.00 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG0056
ParticipantsOG00611
ParticipantsOG0071
ParticipantsOG0082
ParticipantsOG0096
ParticipantsOG0100
ParticipantsOG0112
ParticipantsOG0125
ParticipantsOG0136
ParticipantsOG0147
Title
Measurements
OG000NABelow the level of detection
OG0010± 0
OG0020± 0
OG003
0.0167 hours
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0036
0.250 hours
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0038
0.500 hours
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0038
1.50 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0039
3.00 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0039
24.0 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0039
72.0 hours
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0037
144 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0039
312 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0038
504 hours
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0037
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0039
OG00411
OG0058
OG00612
OG0071
OG0082
OG0096
OG0100
OG0112
OG0125
OG0136
OG0147
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0038
ParticipantsOG00410
ParticipantsOG0056
ParticipantsOG00611
ParticipantsOG0071
ParticipantsOG0082
ParticipantsOG0096
ParticipantsOG0100
ParticipantsOG0112
ParticipantsOG0125
ParticipantsOG0136
ParticipantsOG0147
Title
Measurements
OG000NABelow the level of detection
OG0010.00± 0.00
OG0020.00± 0.00
OG003
Cycle 2
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0039
Cycle 3
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
Cycle 5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0033
Cycle 6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
Cycle 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Cycle 8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Cycle 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Cycle 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Cycle 18
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0039
OG00411
OG0058
OG00612
OG0071
OG0082
OG0096
OG0100
OG0112
OG0125
OG0136
OG0147
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG0056
ParticipantsOG00611
ParticipantsOG0071
ParticipantsOG0082
ParticipantsOG0096
ParticipantsOG0100
ParticipantsOG0112
ParticipantsOG0125
ParticipantsOG0136
ParticipantsOG0147
Title
Measurements
OG000NABelow the level of detection
OG0010.00± 0.00
OG0020.00± 0.00
OG003
Cycle 2
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0039
Cycle 3
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
Cycle 5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0033
Cycle 6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
Cycle 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Cycle 8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Cycle 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Cycle 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Cycle 18
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0038
OG00411
OG0057
OG00612
OG0071
OG0082
OG0096
OG0100
OG0112
OG0125
OG0136
OG0147
Title
Denominators
Categories
Title
Measurements
OG0004410
OG0017130± 1540
OG0028400± 1590
OG00318500± 6140
OG00427700± 6790
OG00545700± 14800
OG00680300± 17400
OG00717200
OG00832500± 9620
OG00951800± 13200
OG01130900± 3180
OG01276500± 14200
OG01331400± 7460
OG01484400± 15500
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0024
OG0039
OG00411
OG0057
OG00612
OG0071
OG0082
OG0096
OG0100
OG0112
OG0125
OG0136
OG0147
Title
Denominators
Categories
Title
Measurements
OG0004300
OG0016810± 1200
OG0029550± 2740
OG00318300± 5780
OG00427300± 6920
OG00545800± 14700
OG00680600± 17700
OG00718400
OG00831400± 8770
OG00952200± 14100
OG01129700± 1700
OG01280800± 16800
OG01331400± 7670
OG01485600± 16000
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0038
OG00411
OG0057
OG00612
OG0071
OG0082
OG0096
OG0100
OG0112
OG0125
OG0136
OG0147
Title
Denominators
Categories
Title
Measurements
OG0002.05
OG0011.00± 0.0726
OG002168± 291
OG0030.710± 0.332
OG0040.658± 0.213
OG0050.981± 0.467
OG0060.817± 0.163
OG0070.98
OG0080.708± 0.0589
OG0090.647± 0.113
OG0110.650± 0.212
OG0121.06± 0.768
OG0130.806± 0.213
OG0141.15± 0.323
XTX202 0.38 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0024
OG0039
OG00411
OG0057
OG00612
OG0071
OG0082
OG0096
OG0100
OG0112
OG0125
OG0136
OG0147
Title
Denominators
Categories
Title
Measurements
OG0002.05
OG0011.00± 0.0726
OG002126± 252
OG0030.694± 0.311
OG0040.680± 0.258
OG0051.05± 0.403
OG0060.838± 0.170
OG0070.98
OG0080.783± 0.0471
OG0090.694± 0.107
OG0110.650± 0.212
OG0121.00± 0.796
OG0130.761± 0.225
OG0141.15± 0.129
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0038
OG00411
OG0057
OG00612
OG0071
OG0082
OG0096
OG0100
OG0112
OG0122
OG0136
OG0143
Title
Denominators
Categories
Title
Measurements
OG000479000
OG001653000± 190000
OG0021050000± 477000
OG0031490000± 478000
OG0042310000± 423000
OG0053770000± 1600000
OG0065720000± 1590000
OG0071490000
OG0082670000± 938000
OG0094670000± 1390000
OG0112760000± 467000
OG0125380000± 651000
OG0132610000± 768000
OG0146170000± 1970000
OG002
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0024
OG0039
OG00411
OG0057
OG00612
OG0071
OG0082
OG0096
OG0100
OG0112
OG0122
OG0136
OG0143
Title
Denominators
Categories
Title
Measurements
OG000469000
OG001639000± 203000
OG0021010000± 404000
OG0031440000± 501000
OG0042160000± 382000
OG0053630000± 1480000
OG0065810000± 1590000
OG0071500000
OG0082630000± 991000
OG0094680000± 1370000
OG0112760000± 484000
OG0125410000± 941000
OG0132580000± 800000
OG0146190000± 2020000
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0012
OG0022
OG0035
OG0049
OG0056
OG00610
OG0071
OG0081
OG0094
OG0100
OG0112
OG0122
OG0133
OG0142
Title
Denominators
Categories
Title
Measurements
OG000NASampling duration is insufficient for calculation
OG001200± 23.8
OG002207± 26.4
OG003238± 43.8
OG004187± 17.5
OG005207± 81.1
OG006189± 31.0
OG007NASampling duration is insufficient for calculation
OG008182± NANot Calculated
OG009185± 36.1
OG011203± 0.813
OG012213± 19.6
OG013192± 53.4
OG014167± 59.7
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0012
OG0022
OG0037
OG0049
OG0056
OG0069
OG0071
OG0081
OG0095
OG0100
OG0112
OG0122
OG0133
OG0142
Title
Denominators
Categories
Title
Measurements
OG000NASampling duration is insufficient for calculation
OG001210± 45.2
OG002208± 22.0
OG003229± 40.8
OG004192± 17.6
OG005205± 81.3
OG006179± 26.7
OG007NASampling duration is insufficient for calculation
OG008185± NANot Calculated
OG009183± 29.8
OG011204± 13.1
OG012252± 27.3
OG013212± 57.7
OG014162± 52.4
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0012
OG0022
OG0035
OG0049
OG0056
OG00610
OG0071
OG0081
OG0094
OG0100
OG0112
OG0122
OG0133
OG0142
Title
Denominators
Categories
Title
Measurements
OG000NASampling duration is insufficient for calculation
OG0010.0461± 0.00774
OG0020.0487± 0.00284
OG0030.0418± 0.0187
OG0040.0406± 0.00625
OG0050.0537± 0.0286
OG0060.0534± 0.0125
OG007NASampling duration is insufficient for calculation
OG0080.0537± NANot Calculated
OG0090.0421± 0.00730
OG0110.0368± 0.00141
OG0120.0404± 0.00424
OG0130.0421± 0.00856
OG0140.0341± 0.00414
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0012
OG0022
OG0037
OG0049
OG0056
OG0069
OG0071
OG0081
OG0095
OG0100
OG0112
OG0122
OG0133
OG0142
Title
Denominators
Categories
Title
Measurements
OG000NAsampling duration is insufficient for calculation
OG0010.0475± 0.00769
OG0020.0489± 0.00269
OG0030.0418± 0.0184
OG0040.0426± 0.00569
OG0050.0556± 0.0288
OG0060.0526± 0.0119
OG007NAsampling duration is insufficient for calculation
OG0080.0533± NANot Calculated
OG0090.0454± 0.00993
OG0110.0369± 0.00216
OG0120.0391± 0.00152
OG0130.0419± 0.0104
OG0140.0340± 0.00443
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0012
OG0022
OG0035
OG0049
OG0056
OG00610
OG0071
OG0081
OG0094
OG0100
OG0112
OG0122
OG0133
OG0142
Title
Denominators
Categories
Title
Measurements
OG000NAsampling duration is insufficient for calculation
OG00113.2± 0.648
OG00214.6± 2.70
OG00313.5± 4.35
OG00410.8± 1.00
OG00513.7± 4.22
OG00614.5± 3.84
OG007NAsampling duration is insufficient for calculation
OG00814.1± NANot Calculated
OG00911.1± 1.95
OG01110.8± 0.370
OG01212.5± 2.45
OG01311.3± 1.85
OG0148.37± 3.93
Phase 1 Part 1A, Dose Escalation- XTX202 0.53 mg/kg
XTX202 0.53 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG011
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG012
Phase 2 Part 2A, Dose Expansion, RCC- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG013
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG014
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0012
OG0022
OG0037
OG0049
OG0056
OG0069
OG0071
OG0081
OG0095
OG0100
OG0112
OG0122
OG0133
OG0142
Title
Denominators
Categories
Title
Measurements
OG000NASampling duration is insufficient for calculation
OG00114.1± 0.767
OG00214.8± 2.36
OG00313.2± 4.94
OG00411.7± 1.32
OG00514.0± 4.02
OG00613.7± 3.96
OG007NASampling duration is insufficient for calculation
OG00814.2± NANot Calculated
OG00911.9± 2.89
OG01110.8± 0.0580
OG01214.2± 2.09
OG01312.3± 1.35
OG0148.11± 3.61
OG003
Phase 1 Part 1A, Dose Escalation- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG004
Phase 1 Part 1A, Dose Escalation- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG005
Phase 1 Part 1A, Dose Escalation- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG006
Phase 1 Part 1A, Dose Escalation- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG007
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.0 mg/kg
XTX202 1.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG008
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 1.4 mg/kg
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG009
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 2.8 mg/kg
XTX202 2.8 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months
OG010
Phase 1 Part 1B, Pharmacodynamics Expansion- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0039
OG00411
OG0058
OG00612
OG0071
OG0082
OG0096
OG0100
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0023
OG0034
OG0045
OG0053
OG0061
OG0070
OG0080
OG0091
OG0100
XTX202 1.4 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.
OG003
Phase 2 Part 2B, Dose Expansion, Melanoma- XTX202 4.0 mg/kg
XTX202 4.0 mg/kg was administered on Day 1 of each 21-day cycle for up to 24 months.