A Study of PYX-201 in Advanced Solid Tumors
Trial Parameters
Brief Summary
The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent/metastatic (R/M) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.
Eligibility Criteria
Inclusion 1. Histologically or cytologically confirmed solid tumors including locally advanced/metastatic HR+ and HER2- breast cancer (post CDK4/6 inhibitor +/- ET, ≤ 2 lines systemic therapy), TNBC (1-3 prior lines including post ADC topo-1 payload), HNSCC (1-2 prior lines including post PD-L1/PD1 and platinum based therapy), and other solid tumor types (≤ 2 lines systemic therapy). 2. Male or non-pregnant, non-lactating female participants age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1. 4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 5. Life expectancy of \>3 months, in the opinion of the Investigator. 6. Corrected QTcF \<470 msec. 7. Adequate hematologic function. 8. Adequate hepatic function. 9. Adequate renal function. 10. Adequate coagulation profile. 11. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample. Exclusion