drugset / Trial / NCT04691375
A Study of PY314 in Subjects With Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open-label, multicenter, first in human, Phase 1a/1b study of PY314 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to standard of care (including pembrolizumab, if approved for that indication).
Timeline
- Start
- 2020-10-29
- Primary completion
- 2023-08-31
- Completion
- 2023-09-22
Outcome
Outcome not reported
Stopped (Business): “Sponsor business decision.”
Publications
- Beckermann KE, Patnaik A, Winer I, Tan W, Bashir B, Kyriakopoulos CE, Sweis RF, Chamberlain M, Rini BI. A phase 1b open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of py314 in combination with pembrolizumab in patients with advanced renal cell carcinoma. Invest New Drugs. 2024 Apr;42(2):179-184. doi: 10.1007/s10637-024-01419-1. Epub 2024 Feb 19.
- Binnewies M, Pollack JL, Rudolph J, Dash S, Abushawish M, Lee T, Jahchan NS, Canaday P, Lu E, Norng M, Mankikar S, Liu VM, Du X, Chen A, Mehta R, Palmer R, Juric V, Liang L, Baker KP, Reyno L, Krummel MF, Streuli M, Sriram V. Targeting TREM2 on tumor-associated macrophages enhances immunotherapy. Cell Rep. 2021 Oct 19;37(3):109844. doi: 10.1016/j.celrep.2021.109844.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PY314 | Monoclonal antibody | 10 mg/kg | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |