A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors
Pyxis Oncology, Inc
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPYX-201
Antibody-Drug Conjugate
Locations (29)
- HonorHealth Research InstituteScottsdale, Arizona
- Ronald Reagan UCLA Medical CenterLos Angeles, California
- SCRI - HealthOne DenverDenver, Colorado
- SCRI - Florida Cancer SpecialistsSarasota, Florida
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- University of Chicago MedicineChicago, Illinois