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Brief Title: TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers
Official Title: A Phase 1/1b Open-label, Dose-escalation and Dose-expansion Study of TPST-1120 as a Single Agent or in Combination With Systemic Anti-Cancer Therapies in Subjects With Advanced Solid Tumors
Study ID: NCT03829436
Brief Summary: This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors.
Detailed Description: This is a phase 1/1b open label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) in adult subjects with selected advanced solid tumors. TPST-1120 will be administered as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors. This trial is composed of dose escalation and dose expansion cohorts.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California - San Francisco, San Francisco, California, United States
Miami Cancer Institute, Miami, Florida, United States
Johns Hopkins University, Baltimore, Maryland, United States
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
Columbia University Medical Center, New York, New York, United States
Carolina BioOncology Institute, Huntersville, North Carolina, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute - TN, Nashville, Tennessee, United States
Name: Robert Stagg, PharmD
Affiliation: Tempest Therapeutics
Role: STUDY_DIRECTOR