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

Completed · Phase 1/Phase 2

Conditions studied: Advanced Malignancies, Metastatic Cancer

In brief

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.

Key facts

Study ID

NCT02923349

Run by

Incyte Biosciences International Sàrl

People needed

87

Starts

2016-10-31

Expected to finish

2019-03-26

Last updated by the study team

2025-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rutgers, The State University of New Jersey — New Brunswick, New Jersey, United States
• New York University Clinical Cancer Center — New York, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Vall d'Hebron Institute of Oncology (VHIO) — Barcelona, Spain
• University Hospital of Laussane (CHUV) — Lausanne, Switzerland
• University College Hospital — London, United Kingdom
• University of Oxford — Oxford, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.