An Open-Label, Dose-Escalation, Safety Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors

Status: Closed to Accrual

Description

This is an open-label, non-randomized Phase 1 / 2 safety study of INCAGN01876 in subjects with advanced or metastatic solid tumors that will be conducted in 2 parts. Part 1 will determine the pharmacologically active dose and / or maximum tolerated dose of INCAGN01876. Part 2 will further evaluate the recommended dose determined in Part 1 in subjects with select tumor types.

Eligibility Criteria

Inclusion Criteria

  • Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent
  • Part 1: Subjects with advanced or metastatic solid tumors
  • Part 2: Subjects with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma
  • Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or subjects who refuse standard treatment
  • Presence of measureable 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
  • 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, noninfectious pneumonitis or history of interstitial lung disease
  • Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation

Locations & Contacts

Connecticut

New Haven
Yale University
Status: Temporarily closed to accrual
Name Not Available

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Approved
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
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 1876-101
Secondary IDs NCI-2016-01221
Clinicaltrials.gov ID NCT02697591