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Brief Title: Study of a PD-1 Inhibitor (JTX-4014) in Subjects With Solid Tumor Malignancies
Official Title: Phase 1 First in Human Study of Programmed Cell Death Receptor-1 (PD-1) Inhibitor Monoclonal Antibody (mAb) JTX-4014 in Adult Subjects With Advanced Refractory Solid Tumor Malignancies
Study ID: NCT03790488
Brief Summary: JTX-4014-101 is a Phase 1, open label, dose escalation clinical study of JTX-4014 in adult subjects with advanced refractory solid tumor malignancies, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
Detailed Description: JTX-4014 is a fully human IgG4 monoclonal antibody designed to specifically bind to PD-1 and block its interaction with its ligands, PD-L1 and PD-L2, to augment anti-tumor T cell activity. This is a Phase 1, first in human, open label, multicenter, dose escalation clinical study to evaluate the safety, tolerability, and PK of JTX-4014 when administered as a single agent to adult subjects with advanced refractory solid tumor malignancies. The intent of this study will be to determine the MTD and RP2D.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Florida Cancer Specialists - Sarasota Cattlemen, Sarasota, Florida, United States
START Midwest - Cancer & Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States
Name: Stew Kroll
Affiliation: Jounce Therapeutics, Inc.
Role: STUDY_DIRECTOR