PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors
Trial Parameters
Brief 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 Criteria
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 (ECOG) performance status (PS): 0-1 for Part A and Part B. 8. Adequate end-organ and hematopoietic function, defined based on the following laboratory results obtained within 7 days prior to the first dose of study treatment \[Day 1\]): 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L (1500/μL), without granulocyte colony-stimulating factor (G-CSF) support. Note that G-CSF may be administered until 14 da