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CompletedPhase 1 / Phase 2NCT02923349
Official study title

A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

Study summary

The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedINCAGN01949

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 24, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Incyte Biosciences International Sàrl

Study sponsor

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: INCAGN01949
02
Explore related studies

How this study is categorized

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

Disease setting
Metastatic or stage IV→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
  • Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
  • Part 1: Subjects with advanced or metastatic solid tumors.
  • Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
  • Presence of measureable disease based on RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status 0 or 1.
Reasons someone may not be able to joinExclusion criteria
  • Laboratory and medical history parameters not within the protocol-defined range.
  • Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug.
  • Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
  • Receipt of a live vaccine within 30 days of planned start of study drug.
  • Active autoimmune disease that required systemic treatment in the past.

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

  • Rutgers, The State University of New JerseyNew Brunswick, New Jersey
  • New York University Clinical Cancer CenterNew York, New York
  • Vanderbilt University Medical CenterNashville, Tennessee
  • MD Anderson Cancer CenterHouston, Texas
  • Vall d'Hebron Institute of Oncology (VHIO)Barcelona
  • University Hospital of Laussane (CHUV)Lausanne
  • University College HospitalLondon
  • University of OxfordOxford

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 24, 2025. Always confirm current availability with the study team.

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