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

NCT06244992 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-03-12

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Pyrotech Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-26
Primary Completion
2025-12-31
Completion
2026-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06244992 on ClinicalTrials.gov