TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers

Completed · Phase 1

Conditions studied: Hepatocellular Carcinoma, Metastatic Castration Resistant Prostate Cancer, Renal Cell Carcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Squamous Cell Carcinoma of Head and Neck, Triple-Negative Breast Cancer, Urothelial Carcinoma, Cholangiocarcinoma, GastroEsophageal Cancer, Pancreatic Cancer, Sarcoma

In brief

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.

Key facts

Study ID

NCT03829436

Run by

Tempest Therapeutics

People needed

38

Starts

2019-03-20

Expected to finish

2022-09-07

Last updated by the study team

2023-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group performance status of 0-1 at enrollment
• Progressive disease or previously untreated tumors for which no standard therapy exists or treatment naïve at the time of study entry are eligible
• Have at least one measurable lesion according to RECIST v1.1
• Subjects with the following histologies are eligible and who are refractory to, have failed, are intolerant to, are ineligible for standard therapy, or for which no standard therapy exists are eligible: Part 1 (Dose Escalation- Monotherapy): RCC, NSCLC, CRC, metastatic castration resistant prostate cancer (mCRPC), cholangiocarcinoma, TNBC, pancreatic cancer, HCC, gastroesophageal cancer, squamous cell carcinoma of head and neck (SCCHN), urothelial bladder cancer (UBC), and sarcoma (liposarcomas and leiomyosarcomas); Part 2 (Dose Escalation-Combination with nivolumab): RCC, HCC, and cholangiocarcinoma; Part 3 (Dose Expansion-Monotherapy): RCC, HCC and cholangiocarcinoma; Part 4 (Dose Expansion-Combination with nivolumab): HCC.

You may not qualify if…

• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, a specimen-collection study or the follow-up period of an interventional study
• Any chemotherapy, monoclonal antibody therapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment within 28 days of commencing TPST-1120 treatment. Targeted therapy such as tyrosine kinase inhibitors within 14 days of commencing first dose of study drug(s)
• For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy:
• Subjects must not have experienced an irAE toxicity that led to permanent discontinuation of prior immunotherapy.
• Any unresolved irAE > Grade 1 with prior immunotherapy treatment.
• Symptomatic, untreated or actively progressing central nervous system metastases
• Have received fibrates within 28 days before first dose of investigational agent

Where it is running

• 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

Full record on ClinicalTrials.gov

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