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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.