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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
allogeneic WTX-212C is an investigational allogeneic engineered red blood cell-based injectable product administered intravenously.
Zhejiang Provincial Hospital
Hangzhou, Zhejiang, China
RECRUITINGIncidence of Dose-Limiting Toxicities (DLTs)
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Within 21 days after the first dose
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Up to 12 months
Maximum Tolerated Dose (MTD)
MTD is defined as the highest dose level at which no more than 1 out of 6 participants experiences a dose-limiting toxicity (DLT) during the first treatment cycle, based on a standard 3+3 dose-escalation design.
Time frame: Within 21 days after the first dose
Pharmacokinetic Parameters (Cmax)
Plasma pharmacokinetic parameters of allogeneic WTX-212C, including maximum observed concentration (Cmax）will be estimated using non-compartmental analysis methods.
Time frame: From first dose up to 12 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria, based on investigator assessment.
Time frame: Up to 12 months
Disease Control Rate (DCR)
DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1 criteria.
Time frame: Up to 12 months
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of allogeneic WTX-212C to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Time frame: Up to 12 months
Incidence of Anti-Drug Antibodies (ADA)
The incidence of anti-drug antibodies (ADA) against allogeneic WTX-212C will be assessed using validated immunoassays.
Time frame: From baseline up to 12 months
Pharmacokinetic Parameters (AUC)
Plasma pharmacokinetic parameters of allogeneic WTX-212C，area under the concentration-time curve (AUC), will be estimated using non-compartmental analysis methods.
Time frame: From first dose up to 12 months
Pharmacokinetic Parameters (Tmax)
Plasma pharmacokinetic parameters of allogeneic WTX-212C, time to maximum concentration (Tmax) will be estimated using non-compartmental analysis methods.
Time frame: From first dose up to 12 months
Pharmacokinetic Parameters (T1/2)
Plasma pharmacokinetic parameters of allogeneic WTX-212C, and terminal elimination half-life (t1/2) will be estimated using non-compartmental analysis methods.
Time frame: From first dose up to 12 months
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