TPST-1495 + Pembrolizumab for Cancer

Recruiting in Palo Alto (17 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 trial is testing a new drug called TPST-1495 alone and with pembrolizumab to treat various advanced cancers. It focuses on patients whose cancers have no remaining standard treatments. TPST-1495 blocks signals that help tumors grow, while pembrolizumab helps the immune system fight the cancer. Pembrolizumab has been widely studied and used in various cancers, showing effectiveness and safety.

Research Team

Samuel Whiting, MD PhD

Principal Investigator

Tempest Therapeutics

Eligibility Criteria

This trial is for adults with advanced solid tumors that are metastatic or unresectable, and no standard therapy remains. It's open to all solid tumor types but focuses on colorectal, head and neck squamous cell, urothelial, endometrial cancers, NSCLC, and gastric adenocarcinomas. Participants must have a life expectancy of at least 12 weeks, adequate organ function without recent transfusions or growth factors.

Inclusion Criteria

My organs and bone marrow work well, and I haven't had transfusions or growth support in the last month.

My liver enzymes are within the required limits.

Hemoglobin ≥ 10.0 g/dL

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Exclusion Criteria

I had a stomach ulcer over a year ago or treated my H. pylori infection.

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.

I haven't needed systemic treatment for an autoimmune or inflammatory disorder in the last 2 years.

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Treatment Details

Interventions

Pembrolizumab (Monoclonal Antibodies)
TPST-1495 (Small Molecule)

Trial OverviewThe study tests TPST-1495 alone or combined with Pembrolizumab in different doses/schedules to find the safest and most effective dose against various solid tumors. The first part determines the maximum tolerated dose; the second part expands testing to specific cancer types.

Participant Groups

5Treatment groups

Experimental Treatment

Group I: TPST-1495 monotherapy dose expansionExperimental Treatment1 Intervention

Subjects will receive selected dose regimen from dose and schedule optimization stage until disease progression

Group II: TPST-1495 monotherapy dose escalationExperimental Treatment1 Intervention

Subjects will receive escalating doses of TPST-1495 administered orally twice daily until maximum tolerated dose is reached or until disease progression

Group III: TPST-1495 monotherapy dose and schedule optimizationExperimental Treatment1 Intervention

Subjects will receive alternative TPST-1495 administration schedules until RP2D for the selected schedule is determined or until disease progression.

Group IV: TPST-1495 in combination with pembrolizumab dose expansionExperimental Treatment2 Interventions

Subjects will receive selected dose regimen from dose and schedule optimization stage until disease progression

Group V: TPST-1495 in combination with pembrolizumab dose and schedule optimizationExperimental Treatment2 Interventions

Subjects will receive alternative TPST-1495 administration schedules in combination with pembrolizumab until RP2D for the selected schedule is determined or until disease progression.