Pyrotech Therapeutics, Inc.
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.
Inclusion Criteria: 1. Voluntarily signed informed consent form (ICF). 2. Ability and willingness to adhere to all study procedures. 3. Male or female patients ≥ 18 years of age at the time of signing the ICF. 4. Locally advanced unresectable or metastatic solid tumor confirmed by histology or cytology 5. For Part A: On tumor imaging, as assessed by RECIST v1.1 and iRECIST, with measurable or unmeasurable disease. For Part B: On tumor imaging, as assessed by RECIST v1.1 and iRECIST, with at least one measurable disease. 6. Life expectancy ≥ 3 months. 7. Eastern Cooperative Oncology Group (ECO…
Eligible patients will receive single-agent PTT-936 administered per orally (PO).
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).