CompletedPhase 1 / Phase 2NCT02697591

A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors

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.

Checked against the public recordLast updated Feb 26, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations8
SponsorIncyte Biosciences International Sàrl
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Incyte Biosciences International Sàrl
Interventions being studied
Drug: INCAGN01876
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • The Angeles Clinic and Research InstituteLos Angeles, California
  • Yale UniversityNew Haven, Connecticut
  • Beth Israel Deaconess Medical CenterBoston, Massachusetts
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Memorial Sloan Kettering at MonmouthMiddletown, New Jersey
  • MSK WestchesterHarrison, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Vanderbilt University Medical CenterNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 26, 2021. Always confirm current availability with the study team.

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