A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors
Advanced Malignancies, Metastatic Cancer
About this trial
This is an interventional treatment trial for Advanced Malignancies focused on measuring Solid tumor, adenocarcinoma of the endometrium, melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), glucocorticoid-induced tumor necrosis factor receptor (GITR)
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The Angeles Clinic and Research Institute
- Yale University
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
- Memorial Sloan Kettering at Monmouth
- MSK Westchester
- Memorial Sloan Kettering Cancer Center
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Phase 1: 20.0 Milligram Per Kilograms (mg/kg) Every 2 Weeks (Q2W)
Phase 1: 0.03 mg/kg Q2W
Phase 1: 0.1 mg/kg Q2W
Phase 1: 0.3 mg/kg Q2W
Phase 1: 1.0 mg/kg Q2W
Phase 1: 3.0 mg/kg Q2W
Phase 1: 5.0 mg/kg Q2W
Phase 1: 10.0 mg/kg Q2W
Phase 1: 400 mg/kg Every 4 Weeks (Q4W)
Phase 2: 300 mg/kg Q2W
Participants 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.
Participants 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.
Participants 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.
Participants 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.
Participants 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.
Participants 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.
Participants 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.
Participants 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.
Participants 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.
Participants 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.