A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors
1 other identifier
interventional
100
1 country
8
Brief Summary
This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2016
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedStudy Start
First participant enrolled
June 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2019
CompletedResults Posted
Study results publicly available
February 26, 2021
CompletedFebruary 26, 2021
February 1, 2021
3.5 years
February 22, 2016
December 16, 2020
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent AE is any AE either reported for first time or worsening of a pre-existing event after the first dose of study drug. Grade 1 AEs is defined as Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 AEs is defined as Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 AEs is defined as the severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living and Grade 4 AEs as life-threatening consequences; urgent intervention indicated. Data is reported for Grade 3 and higher severity for this outcome measure.
From screening through 60 days after end of treatment, up to Month 15
Secondary Outcomes (8)
Maximum Observed Plasma Concentration (Cmax)
Day 1 of Cycles 1 and 6 post-dose
Time to Maximum Concentration (Tmax)
Day 1 of Cycles 1 and 6 post-dose
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)
Day 1 of Cycles 2, 3, 4, 6, and 7 post-dose
Area Under the Plasma Time Curve From Time = 0 to the Last Measurable Concentration (AUC0-t)
Day 1 of Cycles 1 and 6 post-dose
Objective Response Rate (ORR) Per RECIST v1.1 and Modified RECISTv1.1 (mRECIST)
Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
- +3 more secondary outcomes
Study Arms (10)
Phase 1: 20.0 Milligram Per Kilograms (mg/kg) Every 2 Weeks (Q2W)
EXPERIMENTALParticipants received IV infusion of study drug at a dose of 20.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.
Phase 1: 0.03 mg/kg Q2W
EXPERIMENTALParticipants received intravenous (IV) infusion of study drug at a dose of 0.03 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.
Phase 1: 0.1 mg/kg Q2W
EXPERIMENTALParticipants received IV infusion of study drug at a dose of 0.1 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.
Phase 1: 0.3 mg/kg Q2W
EXPERIMENTALParticipants received IV infusion of study drug at a dose of 0.3 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.
Phase 1: 1.0 mg/kg Q2W
EXPERIMENTALParticipants received IV infusion of study drug at a dose of 1.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.
Phase 1: 3.0 mg/kg Q2W
EXPERIMENTALParticipants received IV infusion of study drug at a dose of 3.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.
Phase 1: 5.0 mg/kg Q2W
EXPERIMENTALParticipants received IV infusion of study drug at a dose of 5.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.
Phase 1: 10.0 mg/kg Q2W
EXPERIMENTALParticipants received IV infusion of study drug at a dose of 10.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.
Phase 1: 400 mg/kg Every 4 Weeks (Q4W)
EXPERIMENTALParticipants received IV infusion of study drug at a dose of 400 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.
Phase 2: 300 mg/kg Q2W
EXPERIMENTALParticipants received IV infusion of study drug at a dose of 300 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.
Interventions
Initial cohort dose of INCAGN01876 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.
Eligibility Criteria
You may qualify if:
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Part 1: Participants with advanced or metastatic solid tumors.
- Part 2: Participants with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma.
- Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or participants who refuse standard treatment.
- Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
You may not qualify if:
- Laboratory and medical history parameters not within the protocol-defined range.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy.
- Receipt of a live vaccine within 30 days of planned start of study therapy.
- Active autoimmune disease.
- Prior treatment with any tumor necrosis factor super family agonist.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Evidence of active, non-infectious pneumonitis or history of interstitial lung disease.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
Yale University
New Haven, Connecticut, 06511, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering at Monmouth
Middletown, New Jersey, 07748, United States
MSK Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
Hamid O, Cardin DB, Hodi FS, LoRusso P, Merghoub T, Zappasodi R, Maniyar R, Janik JE, van der Velden MVW, Zhou F, Dong Z, Chen X, Harding JJ. First-in-Human Phase I/II Study of INCAGN01876, a Glucocorticoid-Induced Tumor Necrosis Factor Receptor Agonist, in Patients with Advanced or Metastatic Solid Tumors. Clin Cancer Res. 2025 Oct 1;31(19):4089-4100. doi: 10.1158/1078-0432.CCR-24-4141.
PMID: 40711469DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
John Janik, MD
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2016
First Posted
March 3, 2016
Study Start
June 20, 2016
Primary Completion
December 16, 2019
Study Completion
December 16, 2019
Last Updated
February 26, 2021
Results First Posted
February 26, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share