NCT03829436

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Tempest Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Part 1 TPST-1120	Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression
DRUG	Part 2 TPST-1120 + nivolumab	Subjects will receive escalating doses of TPST-1120 administered orally twice daily
DRUG	Part 3 TPST-1120	Selected dose of TPST-1120 administered orally twice daily until disease progression
DRUG	Part 4 TPST-1120 + nivolumab	Selected dose of TPST-1120 administered orally twice daily in combination with nivolumab administered intravenously every 28 days until MTD is reached for TPST-1120 or until disease progression

Timeline

• Start date: 2019-03-20
• Primary completion: 2022-09-07
• Completion: 2022-09-07
• First posted: 2019-02-04
• Last updated: 2023-07-03

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study