Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
Trial Parameters
Brief Summary
The primary objective of this study is to determine the recommended Phase 2 doses (RP2D(s)) and maximum tolerated dose (MTD) of PYX-201 in combination with pembrolizumab for participants with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria 1. Histologically or cytologically confirmed advanced solid tumors, including first-line (1L) head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple negative breast cancer (TNBC), hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) HNSCC. 2. Male or non-pregnant, non-lactating female participants age ≥18 years. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1. 4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. 5. Life expectancy of \>3 months, in the opinion of the Investigator. 6. Adequate hematologic function. 7. Adequate hepatic function. 8. Adequate renal function. 9. Adequate coagulation profile. 10. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample. Exclusion