TTX-030 in Combination With Immunotherapy and/or Chemothe... | NCT04306900 | Trialant
NCT04306900
Sponsor
Trishula Therapeutics, Inc.
Status
Completed
Last Update Posted
Jul 29, 2025Actual
Enrollment
185Actual
Phase
Phase 1
Conditions
Solid Tumor, Adult
Interventions
TTX-030, budigalimab and mFOLFOX6
TTX-030, budigalimab and docetaxel
TTX-030 and mFOLFOX6
TTX-030 and budigalimab
TTX-030, budigalimab, nab-paclitaxel and gemcitabine
TTX-030 and pembrolizumab
TTX-030, nab-paclitaxel and gemcitabine
Budigalimab and mFOLFOX6
Countries
United States
South Korea
Protocol Section
Identification Module
NCT ID
NCT04306900
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TTX-030-002
Secondary IDs
Not provided
Brief Title
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
Official Title
Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors
Acronym
Not provided
Organization
Trishula Therapeutics, Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2025
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
Mar 30, 2020Actual
Primary Completion Date
Nov 30, 2022Actual
Completion Date
Mar 27, 2024Actual
First Submitted Date
Mar 4, 2020
First Submission Date that Met QC Criteria
Mar 10, 2020
First Posted Date
Mar 13, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jun 20, 2025
Results First Submitted that Met QC Criteria
Jul 9, 2025
Results First Posted Date
Jul 29, 2025Actual
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
Jul 9, 2025
Last Update Posted Date
Jul 29, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Trishula Therapeutics, Inc.INDUSTRY
Collaborators
Name
Class
AbbVie
INDUSTRY
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
This is a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.
This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumor, Adult
Keywords
Gastric (gastroesophageal cancer)
Advanced Solid Tumor
Colorectal cancer
Cancer
Metastatic Solid Tumor
Combination Therapy
CD39
Adenosine Pathway
Immunotherapy Immuno-oncology
PD-1 Checkpoint Inhibitor
Docetaxel
Budigalimab
ABBV-181
TTX-030
Non-small cell lung cancer
Urothelial cell cancer
Pancreatic cancer
Pembrolizumab
Keytruda
Bladder cancer
Gemcitabine
Nab-paclitaxel
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
185Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Combo 1
Experimental
TTX-030 plus budigalimab plus mFOLFOX6
Combination Product: TTX-030, budigalimab and mFOLFOX6
Combo 2
Experimental
TTX-030 plus budigalimab plus docetaxel
Combination Product: TTX-030, budigalimab and docetaxel
Combo 3
Experimental
TTX-030 plus mFOLFOX6
Combination Product: TTX-030 and mFOLFOX6
Combo 4
Experimental
TTX-030 plus pembrolizumab
Combination Product: TTX-030 and pembrolizumab
Combo 5
Experimental
TTX-030 plus budigalimab (selected tumors evaluated in expansion)
Combination Product: TTX-030 and budigalimab
Combo 6
Experimental
TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TTX-030, budigalimab and mFOLFOX6
Combination Product
Dose and schedule per protocol
Combo 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
7 day load + 1 cycle (1 cycle is 28 days)
The Incident of Adverse Events
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
Through study completion, an average of 1 year
Secondary Outcomes
Measure
Description
Time Frame
Confirmed Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with CR or PR.
Through study completion, an average of 1 year
Best Response (BOR)
The BOR was defined as the best response (in the order of CR, PR, stable disease, and PD) by RECIST 1.1 documented from first dose until the end of study, first disease progression, death, or start of new anticancer therapy, whichever was earliest.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Abbreviated Inclusion Criteria:
Age 18 years or older, is willing and able to provide informed consent
Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
Life expectancy > 12 weeks
ECOG performance status of 0-1
Abbreviated Exclusion Criteria:
History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
History of severe autoimmune disease
Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
110 Years
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
HonorHealth Research Institute
Scottsdale
Arizona
85258
United States
City of Hope Medical Center Clinical Trials Office
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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
Sep 9, 2021
Jun 13, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group 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
Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Combo 7
Experimental
TTX-030 plus nab-paclitaxel + gemcitabine
Combination Product: TTX-030, nab-paclitaxel and gemcitabine
Combo 8
Experimental
Budigalimab plus mFOLFOX6
Combination Product: Budigalimab and mFOLFOX6
TTX-030, budigalimab and docetaxel
Combination Product
Dose and schedule per protocol
Combo 2
TTX-030 and mFOLFOX6
Combination Product
Dose and schedule per protocol
Combo 3
TTX-030 and budigalimab
Combination Product
Dose and schedule per protocol
Combo 5
TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Combination Product
Dose and schedule per protocol
Combo 6
TTX-030 and pembrolizumab
Combination Product
Dose and schedule per protocol
Combo 4
TTX-030, nab-paclitaxel and gemcitabine
Combination Product
Dose and schedule per protocol
Combo 7
Budigalimab and mFOLFOX6
Combination Product
Dose and schedule per protocol
Combo 8
Through study completion, an average of 1 year
Duration of Response (DOR)
DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Through study completion, an average of 1 year
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD per RECIST 1.1
Through study completion, an average of 1 year
Progression-free Survival (PFS)
PFS is measured from documentation of progression or death from any cause, whichever occurs first
Through study completion, an average of 1 year
Overall Survival (OS)
OS was defined as the time interval from the first dose of study treatment to death from any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Medians, Q1, and Q3 of OS and the proportion of participants who were alive at 3, 6, 9, and 12 months from Study Day 1 were derived using KM methods.
Through study completion, an average of 1 year
Pharmacokinetics (PK)
Serum concentrations of TTX-030 will be tabulated
Cycles 1-4 (each cycle is 21-28 days)
Duarte
California
91010
United States
University of Southern California
Los Angeles
California
90007
United States
Cedars-Sinai Medical Center
Los Angeles
California
90048
United States
UCLA Hematology/Oncology
Los Angeles
California
90404
United States
Chao Family Comprehensive CC, UCI
Orange
California
92868
United States
UC Davis Comprehensive Cancer Center
Sacramento
California
95817
United States
Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine
Miami
Florida
33136
United States
Ocala Oncology Center PL
Ocala
Florida
34474
United States
Orlando Health UF Health Cancer Center
Orlando
Florida
32835
United States
IACT Health - John B. Amos Cancer Center
Columbus
Georgia
31904
United States
University of Chicago Medical Center
Chicago
Illinois
60637
United States
Norton Cancer Institute
Louisville
Kentucky
40202
United States
Ochsner Medical Center
New Orleans
Louisiana
70121
United States
Nebraska Cancer Center Oncology Hematology West P.C.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
FG002
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
FG003
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
FG007
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
FG008
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
FG009
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
FG010
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
BG002
Cohort 12 - Gastric (Budigalimab + mFOLFOX6
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
BG003
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
BG007
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
BG008
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
BG009
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
BG010
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG00144
BG00225
BG0036
BG0047
BG00528
BG00617
BG00714
BG0085
BG00923
BG0108
BG011185
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00065.9± 9.40
BG00159.5± 12.51
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG00118
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
South Korea
Title
Measurements
BG0000
BG00124
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
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
Only Cohort 1 and Cohort 2 are the safety lead-in cohorts and were evaluated for DLTs.
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG002
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG003
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG007
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG008
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG009
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG010
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
Units
Counts
Participants
OG0006
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG0010
OG0020
OG003
Primary
The Incident of Adverse Events
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
This set included all participants who received at least 1 dose or any partial dose of study treatment. The Safety Analysis Set was used for safety endpoints and study treatment administration.
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG002
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Secondary
Confirmed Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with CR or PR.
The ORR was defined as the proportion of participants who achieved a BOR of either CR or PR as derived based on the lesion measurement provided by the Investigator per RECIST v1.1. Confirmed ORR was defined as 2 disease response assessments showing objective response (CR or PR) at least 4 weeks apart and was presented with corresponding 2-sided 95% confidence intervals (CIs) based on the Clopper-Pearson method.
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Secondary
Best Response (BOR)
The BOR was defined as the best response (in the order of CR, PR, stable disease, and PD) by RECIST 1.1 documented from first dose until the end of study, first disease progression, death, or start of new anticancer therapy, whichever was earliest.
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG002
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Secondary
Duration of Response (DOR)
DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG001
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG002
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Secondary
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD per RECIST 1.1
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG002
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Secondary
Progression-free Survival (PFS)
PFS is measured from documentation of progression or death from any cause, whichever occurs first
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG002
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Secondary
Overall Survival (OS)
OS was defined as the time interval from the first dose of study treatment to death from any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Medians, Q1, and Q3 of OS and the proportion of participants who were alive at 3, 6, 9, and 12 months from Study Day 1 were derived using KM methods.
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG002
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Secondary
Pharmacokinetics (PK)
Serum concentrations of TTX-030 will be tabulated
Pharmacokinetic Parameters of Serum TTX-030 by Treatment and Visit at C1D1
Participants were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG001
TTX-030 (Load+Q2W) + mFOLFOX6 (Q2W)
Participants were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Time Frame
Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment
Description
Safety population = all participants who received at least one dose or any partial dose of TTX-030.
Participants in Cohort 1 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Cohort 3B were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15, plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
13
44
27
44
43
44
EG002
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
7
25
16
25
25
25
EG003
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375 mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
8
17
8
17
17
17
EG007
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
7
14
4
14
14
14
EG008
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
2
5
2
5
1
5
EG009
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
10
23
10
23
23
23
EG010
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D001745
Urinary Bladder Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000719868
budigalimab
D000077143
Docetaxel
C520255
130-nm albumin-bound paclitaxel
D000093542
Gemcitabine
C582435
pembrolizumab
Ancestor Terms
ID
Term
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
D006571
Heterocyclic Compounds
D003841
Deoxycytidine
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
Browse Leaves
Not provided
Browse Branches
Not provided
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Between 18 and 65 years
BG0004
BG00131
BG00214
BG0034
BG0044
BG00512
BG0066
BG0079
BG0083
BG00912
BG0103
BG011102
>=65 years
BG0004
BG00113
BG00211
BG0032
BG0043
BG00516
BG00611
BG0075
BG0082
BG00911
BG0105
BG01183
63.2
± 8.70
BG00362.5± 6.28
BG00465.7± 7.95
BG00565.7± 6.83
BG00668.2± 9.5
BG00761.4± 10.57
BG00865.2± 6.57
BG00961± 15.54
BG01066.4± 7.42
BG01163.1± 10.77
1
BG0032
BG0040
BG00513
BG0066
BG0075
BG0081
BG0098
BG0101
BG01157
Male
BG0006
BG00126
BG00224
BG0034
BG0047
BG00515
BG00611
BG0079
BG0084
BG00915
BG0107
BG011128
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Asian
BG0000
BG00125
BG00222
BG0032
BG0040
BG0059
BG0062
BG0072
BG0081
BG0093
BG0103
BG01169
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Black or African American
BG0001
BG0011
BG0020
BG0030
BG0041
BG0052
BG0061
BG0072
BG0080
BG0091
BG0100
BG0119
White
BG0007
BG00117
BG0023
BG0033
BG0046
BG00516
BG00612
BG00710
BG0083
BG00917
BG0105
BG01199
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Unknown or Not Reported
BG0000
BG0011
BG0020
BG0031
BG0040
BG0051
BG0062
BG0070
BG0081
BG0092
BG0100
BG0118
21
BG0032
BG0040
BG0058
BG0062
BG0070
BG0081
BG0090
BG0103
BG01161
United States
Title
Measurements
BG0008
BG00120
BG0024
BG0034
BG0047
BG00520
BG00615
BG00714
BG0084
BG00923
BG0105
BG011124
0
OG0047
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
0
OG0047
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG003
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG007
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG008
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG009
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG010
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
Units
Counts
Participants
OG0008
OG00144
OG00225
OG0036
OG0047
OG00528
OG00617
OG00714
OG0085
OG00923
OG0108
Title
Denominators
Categories
Title
Measurements
OG0008
OG00144
OG00225
OG0036
OG0047
OG00528
OG00617
OG00714
OG0085
OG00923
OG0108
OG002
Cohort 12 - Gastric (Budigalimab + mFOLFOX6)
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG003
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG007
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG008
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG009
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG010
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
Units
Counts
Participants
OG0007
OG00141
OG00223
OG0034
OG0043
OG00527
OG00617
OG00712
OG0085
OG00922
OG0108
Title
Denominators
Categories
Title
Measurements
OG00014.3(0.4 to 57.9)
OG00156.1(39.7 to 71.5)
OG00269.6(47.1 to 86.8)
OG00375.0(19.4 to 99.4)
OG0040(0.0 to 41.0)
OG00533.3(16.5 to 54.0)
OG00623.5(6.8 to 49.9)
OG0070.0(0.0 to 26.5)
OG0080.0(0.0 to 52.2)
OG0099.1(1.1 to 29.2)
OG01012.5(0.3 to 52.7)
OG003
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG007
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG008
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG009
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG010
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG005
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG006
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
Units
Counts
Participants
OG00023
OG00116
OG0023
OG0039
OG0044
OG0052
OG0061
Title
Denominators
Categories
Title
Measurements
OG00013
OG0014
OG0023
OG0034
OG0044
OG0051
OG0060
OG003
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG007
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG008
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG009
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG010
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
Units
Counts
Participants
OG0007
OG00141
OG00223
OG0034
OG0047
OG00527
OG00617
OG00712
OG0085
OG00922
OG0108
Title
Denominators
Categories
Title
Measurements
OG0003
OG00137
OG00222
OG0033
OG0042
OG00522
OG00614
OG0073
OG0081
OG0097
OG0101
OG003
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG007
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG008
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG009
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG010
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
Units
Counts
Participants
OG0007
OG00141
OG00223
OG0034
OG0047
OG00527
OG00617
OG00712
OG0085
OG00922
OG0108
Title
Denominators
Categories
Title
Measurements
PD
OG0005
OG00127
OG0029
OG0034
OG0043
OG00514
OG00615
OG00710
OG0083
OG00917
OG0106
Death
OG0001
OG0012
OG0023
OG0030
OG004
Participants censored
OG0001
OG00112
OG00211
OG0030
OG004
Participants in Cohort 12 were administered IV budigalimab at a dose of 500 mg (Q4W) on Day 1 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
OG003
Cohort 3A - Gastric (TTX-030 + mFOLFOX6)
Participants in Cohort 3A were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus mFOLFOX6 over 48 hours (Q2W) on Day 1 and 15 of each 28-day cycle.
Participants in Safety Lead-in Cohort 2 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab 375mg Q3W plus docetaxel at a dose of 75 mg/m2 Q3W on Day 1 of each 21-day treatment cycle.
Participants in Cohort 9 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants in Cohort 11 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG007
Cohort 4 - CRC (TTX-030 + Budigalimab)
Participants in Cohort 4 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG008
Cohort 6 - HNSCC (TTX-030 + Budigalimab)
Participants in Cohort 6 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG009
Cohort 8 - GEC (TTX-030 + Budigalimab)
Participants in Cohort 8 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG010
Cohort 10 - UCC (TTX-030 + Pembrolizumab)
Participants in Cohort 10 were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.
Participants were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus budigalimab at a dose of 500 mg (Q4W) on Day 1 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
Participants were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 20 mg/kg Q2W on Days 1 and 15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
OG005
TTX-030 (Load+Q3W) + Budigalimab (Q3W)
Participants were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus budigalimab at a dose of 375 mg Q3W on Day 1 of each 21-day treatment cycle.
OG006
TTX-030 (Load+Q3W) + Pembrolizumab (Q3W)
Participants were administered IV TTX-030 at a loading dose of 40 mg/kg 7 days before Cycle 1 Day 1 followed by treatment with 30 mg/kg Q3W plus pembrolizumab at a dose of 200 mg Q3W on Day 1 of each 21-day treatment cycle.