Overview
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.
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.
Eligibility
Inclusion Criteria:
- Age 18-75 years
- Histologically or cytologically confirmed advanced solid tumors
- At least one measurable lesion per RECIST 1.1
- ECOG performance status ≤1
- Adequate organ function
- Life expectancy ≥12 weeks
Exclusion Criteria:
- Uncontrolled serious medical conditions
- Active or uncontrolled infections
- Symptomatic or unstable CNS metastases
- History of severe hypersensitivity to biologic agents
- Autoimmune diseases requiring systemic treatment
- Prior severe immune-related adverse events
- Conditions affecting red blood cell integrity
