A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of... | NCT02923349 | Trialant
NCT02923349
Sponsor
Incyte Biosciences International Sàrl
Status
Completed
Last Update Posted
Aug 24, 2025Actual
Enrollment
87Actual
Phase
Phase 1Phase 2
Conditions
Advanced Malignancies
Metastatic Cancer
Interventions
INCAGN01949
Countries
United States
Spain
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02923349
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCAGN 1949-101
Secondary IDs
ID
Type
Description
Link
2016-002079-93
EudraCT Number
Brief Title
A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
Official Title
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Aug 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
Oct 31, 2016Actual
Primary Completion Date
Mar 26, 2019Actual
Completion Date
Mar 26, 2019Actual
First Submitted Date
Oct 3, 2016
First Submission Date that Met QC Criteria
Oct 3, 2016
First Posted Date
Oct 4, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 26, 2020
Results First Submitted that Met QC Criteria
May 6, 2020
Results First Posted Date
May 12, 2020Actual
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
Aug 21, 2025
Last Update Posted Date
Aug 24, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte Biosciences International SàrlINDUSTRY
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
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Malignancies
Metastatic Cancer
Keywords
Solid tumor
adenocarcinoma of the endometrium
ovarian cancer
renal cell carcinoma
melanoma
non-small cell lung cancer
OX40
immunoglobulin G monoclonal antibody
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
87Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
INCAGN01949
Experimental
Drug: INCAGN01949
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCAGN01949
Drug
Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
From screening through 60 days after end of treatment, up to 11 months
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
Part 1: Subjects with advanced or metastatic solid tumors.
Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
Presence of measureable disease based on RECIST v1.1.
Eastern Cooperative Oncology Group performance status 0 or 1.
Exclusion Criteria:
Laboratory and medical history parameters not within the protocol-defined range.
Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug.
Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
Receipt of a live vaccine within 30 days of planned start of study drug.
Active autoimmune disease that required systemic treatment in the past.
Davis EJ, Martin-Liberal J, Kristeleit R, Cho DC, Blagden SP, Berthold D, Cardin DB, Vieito M, Miller RE, Hari Dass P, Orcurto A, Spencer K, Janik JE, Clark J, Condamine T, Pulini J, Chen X, Mehnert JM. First-in-human phase I/II, open-label study of the anti-OX40 agonist INCAGN01949 in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e004235. doi: 10.1136/jitc-2021-004235.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 129 participants were screened for this study, of which 42 participants were screen failures and 87 participants were randomized to treatment.
Recruitment Details
The study was conducted at 4 different sites in US, 1 site in Switzerland,1 site in Spain and 2 sites in the United Kingdom.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
FG001
PART 1 Dose 2 (20 mg)
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
Aug 15, 2017
May 6, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
France
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
N/A
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
INCAGN01949
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Objective Response Rate Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Baseline and every 8 weeks,up to 11 months
Duration of Response Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Baseline and every 8 weeks, up to 11 months
Progression-free Survival Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Baseline and every 8 weeks, up to 11 months
Duration of Disease Control Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Baseline and every 8 weeks, up to 11 months
Time to Maximum Concentration of INCAGN01949 in Plasma
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Summary of Trough Concentrations(Cmin) of INCAGN01949
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
New York
New York
10016
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona
08035
Spain
University Hospital of Laussane (CHUV)
Lausanne
1011
Switzerland
University College Hospital
London
NW1 2PG
United Kingdom
University of Oxford
Oxford
OX3 7LE
United Kingdom
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
FG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
FG003
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
FG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
FG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
FG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
FG0004 subjects
FG0014 subjects
FG00222 subjects
FG00318 subjects
FG00423 subjects
FG00512 subjects
FG0064 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0032 subjects
FG0044 subjects
FG0055 subjects
FG0061 subjects
NOT COMPLETED
FG0004 subjects
FG0014 subjects
FG00217 subjects
FG00316 subjects
FG00419 subjects
FG0057 subjects
FG0063 subjects
Type
Comment
Reasons
Other
FG0001 subjects
FG0012 subjects
FG0024 subjects
FG0031 subjects
FG0043 subjects
FG0050 subjects
FG0061 subjects
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0028 subjects
FG00310 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0034 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
BG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
BG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
BG003
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
BG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
BG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
BG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0014
BG00222
BG00318
BG00423
BG00512
BG0064
BG00787
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Geometric Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054.3± 16.24
BG00163.8± 12.63
BG00256.8± 14.27
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White/Caucasian
Title
Measurements
BG0004
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
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
Secondary
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
Posted
Mean
Standard Deviation
ng/ml
Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
ID
Title
Description
OG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG003
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
Units
Counts
Participants
OG0004
OG0014
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG0001630± 735
OG0015820± 324
OG00222300± 32800
OG003
Secondary
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
Posted
Geometric Mean
Standard Deviation
ug*hr/mL
Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
ID
Title
Description
OG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG003
PART 1 Dose 4 (200 mg)
Secondary
Objective Response Rate Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
Posted
Count of Participants
Participants
Baseline and every 8 weeks,up to 11 months
ID
Title
Description
OG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG003
PART 1 Dose 4 (200 mg)
Secondary
Duration of Response Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
The Full Analysis Set population included all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with response
Posted
Median
Full Range
days
Baseline and every 8 weeks, up to 11 months
ID
Title
Description
OG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG003
Secondary
Progression-free Survival Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
Posted
Median
Full Range
Days
Baseline and every 8 weeks, up to 11 months
ID
Title
Description
OG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG003
PART 1 Dose 4 (200 mg)
Secondary
Duration of Disease Control Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with CR, PR, and SD
Posted
Median
Full Range
Days
Baseline and every 8 weeks, up to 11 months
ID
Title
Description
OG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG003
Primary
Number of Participants With Treatment-related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
Posted
Count of Participants
Participants
From screening through 60 days after end of treatment, up to 11 months
ID
Title
Description
OG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG003
PART 1 Dose 4 (200 mg)
Secondary
Time to Maximum Concentration of INCAGN01949 in Plasma
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
Posted
Median
Full Range
hr
Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
ID
Title
Description
OG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG003
PART 1 Dose 4 (200 mg)
Secondary
Summary of Trough Concentrations(Cmin) of INCAGN01949
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
ID
Title
Description
OG000
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG003
Time Frame
From screening through 60 days after end of treatment, up to 11 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
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
1
4
1
4
4
4
EG001
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
0
4
1
4
4
4
EG002
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
2
22
8
22
21
22
EG003
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
4
18
9
18
17
18
EG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
2
23
9
23
22
23
EG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
3
12
5
12
10
12
EG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
0
4
1
4
4
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected22 at risk
EG0030 affected18 at risk
EG0041 affected23 at risk
EG0052 affected12 at risk
EG0060 affected4 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected22 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected22 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected22 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Embolism
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
General physical health deterioration
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected22 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected22 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected22 at risk
EG003
Myelitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected22 at risk
EG003
Oedema
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected22 at risk
EG003
Pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected22 at risk
EG003
Pyrexia
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected22 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected22 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
D000230
Adenocarcinoma
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D007680
Kidney Neoplasms
D014571
Urologic Neoplasms
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D018358
Neuroendocrine Tumors
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009380
Neoplasms, Nerve Tissue
D018326
Nevi and Melanomas
D012878
Skin Neoplasms
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
12 subjects
FG0053 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0062 subjects
1 subjects
FG0051 subjects
FG0060 subjects
2 subjects
FG0053 subjects
FG0060 subjects
58.9
± 12.78
BG00458.1± 12.44
BG00561.3± 9.93
BG00652.8± 24.50
BG00758.2± 13.24
14
BG00312
BG00417
BG0053
BG0062
BG00753
Male
BG0002
BG0011
BG0028
BG0036
BG0046
BG0059
BG0062
BG00734
19
BG00317
BG00423
BG0059
BG0064
BG00779
Asian
Title
Measurements
BG0000
BG0011
BG0022
BG0030
BG0040
BG0051
BG0060
BG0074
Other
Title
Measurements
BG0000
BG0010
BG0021
BG0031
BG0040
BG0050
BG0060
BG0072
Black/African American
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0052
BG0060
BG0072
1
BG0031
BG0040
BG0051
BG0061
BG0074
Not Hispanic or Latino
Title
Measurements
BG0004
BG0014
BG00219
BG00316
BG00422
BG00511
BG0062
BG00778
Not Reported
Title
Measurements
BG0000
BG0010
BG0021
BG0031
BG0041
BG0050
BG0061
BG0074
Other
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0071
17
OG00421
OG0057
OG0064
39200
± 10300
OG00484900± 76700
OG005207000± 45500
OG006347000± 130000
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
Units
Counts
Participants
OG0004
OG0014
OG00221
OG00317
OG00421
OG0057
OG0064
Title
Denominators
Categories
cycle 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG00221
ParticipantsOG00317
ParticipantsOG00421
ParticipantsOG0057
ParticipantsOG0064
Title
Measurements
OG000185± 81.7
OG001904± 197
OG0022370± 841
OG003
cycle 6
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0033
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
Units
Counts
Participants
OG0004
OG0014
OG00222
OG00318
OG00423
OG00512
OG0064
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG005192± 192(192 to 192)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
Units
Counts
Participants
OG0004
OG0014
OG00222
OG00318
OG00423
OG00512
OG0064
Title
Denominators
Categories
Title
Measurements
OG00057± 55(55 to 59)
OG00147.5± 29(29 to 112)
OG00254.0± 23(23 to 216)
OG00356.0± 26(26 to 281)
OG00452.0± 1(1 to 166)
OG005125.0± 21(21 to 298)
OG00646.5± 42(42 to 53)
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
Units
Counts
Participants
OG0001
OG0011
OG0028
OG0037
OG0043
OG0057
OG0060
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG00157(57 to 57)
OG00264(1 to 160)
OG00357(1 to 225)
OG004NA(1 to 112)The numbers reported were censored durations of stable disease for the participants. Median is not estimable as Kaplan-Meier method requires at least 1 event to determine where the curve hits 50% rate of estimated durations
OG005120(1 to 249)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
Units
Counts
Participants
OG0004
OG0014
OG00222
OG00318
OG00423
OG00512
OG0064
Title
Denominators
Categories
Title
Measurements
OG0004
OG0014
OG00221
OG00317
OG00422
OG00511
OG0064
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
Units
Counts
Participants
OG0004
OG0014
OG00221
OG00317
OG00421
OG0057
OG0064
Title
Denominators
Categories
cycle 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG00221
ParticipantsOG00317
ParticipantsOG00421
ParticipantsOG0057
ParticipantsOG0064
Title
Measurements
OG0000.64(0.6 to 4.4)
OG0012.53(0.55 to 4.5)
OG0024.3(0.50 to 25.2)
OG003
cycle 6
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0033
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG004
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG005
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
OG006
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors