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

Recruiting in Pittsburgh (>99 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Tempest Therapeutics

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Robert Stagg, PharmD

Principal Investigator

Tempest Therapeutics

Eligibility Criteria

Inclusion Criteria

Eastern Cooperative Oncology Group performance status of 0-1 at enrollment

Have at least one measurable lesion according to RECIST v1.1

You have a tumor that is growing and cannot be treated with standard therapy, or you have not received any treatment for your tumor before.

Exclusion Criteria

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.

Treatment Details

Interventions

• Nivolumab (Monoclonal Antibodies)
• TPST-1120 (Small Molecule)

Participant Groups

Group I: Part 4 TPST-1120 + nivolumab Experimental Treatment 1 Intervention

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

Group II: Part 3 TPST-1120 Experimental Treatment 1 Intervention

Selected dose of TPST-1120 administered orally twice daily until disease progression

Group III: Part 2 TPST-1120 + nivolumab Experimental Treatment 1 Intervention

Subjects will receive escalating doses 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.

Group IV: Part 1 TPST-1120 Experimental Treatment 1 Intervention

Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression

Nivolumab is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Tempest Therapeutics

Lead Sponsor

Trials

4

Recruited

1,500+