Phase 1 / 2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

Status: Active

Description

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

Eligibility Criteria

Inclusion Criteria

  • 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 cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma.
  • Presence of measurable disease based on 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
  • 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).

Locations & Contacts

California

San Diego
University of California San Diego
Status: In review
Name Not Available

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Incyte Biosciences International Sàrl

Trial IDs

Primary ID INCAGN 1876-201
Secondary IDs NCI-2017-01296
Clinicaltrials.gov ID NCT03126110