Breast Cancer Clinical Trial

A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
Phase 1: Subjects with advanced or metastatic solid tumors.
Phase 1: Subjects who have disease progression after treatment with available therapies.
Phase 2: Subjects with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC and are considered refractory to prior PD-1/L1 therapy.
Presence of measurable 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.
Active autoimmune disease.
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.
Known history of human immunodeficiency virus (HIV); HIV 1/2 antibodies.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

52

Study ID:

NCT03241173

Recruitment Status:

Completed

Sponsor:

Incyte Biosciences International Sàrl

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There are 14 Locations for this study

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The University of Alabama Birmingham (UAB)
Birmingham Alabama, 90025, United States
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale Arizona, 85258, United States
The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States
Mount Sinai Medical Center of Florida, Inc.
Miami Florida, 33140, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
John Theurer Cancer Center At Hackensack UMC
Hackensack New Jersey, 07601, United States
Rutgers, The State University
New Brunswick New Jersey, 08901, United States
New York University Clinical Cancer Center
New York New York, 10016, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
Carolina BioOncology Institute
Huntersville North Carolina, 28078, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Sarah Cannon Research Institute, LLC (SCRI)
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

52

Study ID:

NCT03241173

Recruitment Status:

Completed

Sponsor:


Incyte Biosciences International Sàrl

How clear is this clinincal trial information?

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