NCT06244992

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Pyrotech Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	PTT-936	Eligible patients will receive single-agent PTT-936 administered per orally (PO).
DRUG	Combination 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).

Timeline

• Start date: 2024-01-26
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2024-02-06
• Last updated: 2025-03-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study