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

NCT03829436 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-07-03

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Tempest Therapeutics

    lead INDUSTRY

Principal Investigators

  • Robert Stagg, PharmD · Tempest Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2022-09-07
Completion
2022-09-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829436 on ClinicalTrials.gov