NCT05025085
Recruiting
August 27, 2021
February 1, 2022
Brief summary:
This study is a multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AGEN1777 as a single agent and when used in combination with a PD-1 inhibitor in participants with advanced, metastatic solid tumors.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: AGEN1777 in combination with a PD-1 inhibitor 3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days. |
Drug: AGEN1777 An immunoglobulin gamma (IgG1) antibody Drug: a PD-1 inhibitor Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody |
Experimental: Monotherapy with AGEN1777 3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days [3 weeks]). |
Drug: AGEN1777 An immunoglobulin gamma (IgG1) antibody |
Key Inclusion Criteria: Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no acceptable standard therapy available or progressed on or after standard therapies. Measurable disease on baseline imaging based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key Exclusion Criteria: Active infection requiring treatment. Lack of recovery for participants who had major surgical procedure within 4 weeks prior to first dose of protocol therapy. Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication. Corrected QT interval (QTc) (corrected for heart rate using Fridericia's formula prolongation) >480 msec at screening except for right bundle branch block.
Contact: Agenus, Inc. Clinical Trial Information 781-674-4265 clinicaltrialinfo@agenusbio.com
United States, Michigan
START Midwest
Grand Rapids
United States, Ohio
University of Cincinnati Cancer Center
Cincinnati
United States, Oregon
Providence Cancer Institute
Portland
United States, Rhode Island
Lifespan Cancer Institute
Providence
United States, Texas
Mary Crowley Cancer Research
Dallas
United States, Texas
MD Anderson Cancer Center Thoracic-Head & Neck Med Onc
Houston
Agenus Inc.
Bristol-Myers Squibb
Study Director: Medical Director Agenus Inc.