Allogeneic WTX-212C in Advanced Solid Tumors
brief summary
This is a multicenter, open-label, single-arm Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of allogeneic WTX-212C, an investigational allogeneic engineered red blood cell (RBC)-based product, in patients with advanced solid tumors who have failed standard therapies or have no available standard treatment options. The study consists of a dose-escalation phase using a 3+3 design followed by a dose-expansion phase. Participants will receive allogeneic WTX-212C via intravenous infusion. Tumor assessments will be performed every 6 weeks according to RECIST 1.1.
detailed description
This Phase I study aims to characterize the safety profile, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), pharmacokinetics, immunogenicity, and preliminary efficacy of allogeneic WTX-212C in patients with advanced solid tumors.
The dose-escalation phase will follow a traditional 3+3 design with predefined dose levels. The dose-expansion phase will further evaluate safety, PK, and antitumor activity at selected dose levels.
Exploratory analyses will include immune profiling, tumor microenvironment assessment, and evaluation of biomarkers such as PD-1/PD-L1 expression, tumor mutational burden (TMB), and microsatellite instability (MSI) status.
official title
A Multicenter, Open-label, Single-arm Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Allogeneic WTX-212C Engineered Red Blood Cell Injection in Patients With Advanced Solid Tumors