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Brief Title: AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Subjects With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy
Official Title: Phase 1/2, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of an Anti-CTLA-4 Human Monoclonal Antibody (AGEN1884) in Subjects With Advanced or Refractory Cancer and in Subjects Who Have Progressed During Treatment With a PD 1/PD-L1 Inhibitor as Their Most Recent Therapy
Study ID: NCT02694822
Brief Summary: This is an open-label, Phase 1/2, multicenter study to evaluate the safety, PK, and PD of an anti-CTLA-4 human monoclonal antibody (AGEN1884) in subjects with advanced or refractory cancer and in subjects who have progressed during treatment with a PD-1/PD-L1 inhibitor as their most recent therapy. The phase 1 portion of the study has been completed; It enrolled adult subjects with refractory, advanced cancer in a 3+3 dose escalation cohort. The phase 2 portion consists of up to 60 patients who have progressed during treatment with an approved or investigational PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
University of Miami Miller School of Medicine, Miami, Florida, United States
Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, United States
Ochsner Cancer Institute, New Orleans, Louisiana, United States
Atlantic Health System/Morristown Medical Center, Morristown, New Jersey, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Texas Oncology - Austin Midtown, Austin, Texas, United States
Texas Oncology, Tyler Texas, Tyler, Texas, United States
Name: Medical Director
Affiliation: Agenus Inc.
Role: STUDY_DIRECTOR