RecruitingPhase 1Phase 2NCT06244992

PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) Activator, Alone or in Combination With Anti-PD-1/L1 in Patients With Locally Advanced or Metastatic Solid Tumors

Sponsor

Pyrotech Therapeutics, Inc.

Enrollment

68 participants

Start Date

Jan 26, 2024

Study Type

INTERVENTIONAL

Conditions

Locally Advanced or Metastatic Solid Tumors

Summary

This Phase 1/2a study will explore the safety and efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) activator, used alone or in combination with anti-PD-1/L1 therapy in patients with locally advanced or metastatic solid tumors. The study is divided into two parts: Phase 1 (Part A) focuses on determining the pharmaceutically active dosage range and evaluating the safety profile of PTT-936 when administered as a monotherapy. Phase 2a (Part B) will assess the safety and efficacy of PTT-936 combined with anti-PD-1/L1 therapy in patients suitable for anti- PD-1/L1 monotherapy. The study aims to understand how PTT-936, alone or in combination, impacts tumor progression and patients' overall response.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Combination of PTT-936 and anti-PD-1/L1 therapy and a drug called PTT-936 for people with locally advanced or metastatic solid tumors. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPTT-936

Eligible patients will receive single-agent PTT-936 administered per orally (PO).

DRUGCombination of PTT-936 and anti-PD-1/L1 therapy

Eligible patients will receive combination treatment consisting of PTT-936 administered PO in combination with a Standard of Care (SOC) regimen of an anti-PD-1/L1 agent administered intravenously (IV).