Status:
TERMINATED
INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Lead Sponsor:
Incyte Biosciences International Sàrl
Conditions:
Advanced Malignancies
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
Eligibility Criteria
Inclusion
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Phase 1: Subjects with advanced or metastatic solid tumors.
- Phase 1: Subjects who have disease progression after treatment with available therapies.
- Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma.
- Presence of measurable disease based on RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
Exclusion
- Laboratory and medical history parameters not within the Protocol-defined range
- Prior treatment with any tumor necrosis factor super family agonist.
- 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.
- Active autoimmune disease.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
- Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03277352
Start Date
November 21 2017
End Date
July 1 2020
Last Update
July 22 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601