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| Name | Class |
|---|---|
| Westlake Therapeutics | INDUSTRY |
| First People's Hospital of Hangzhou | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Allogeneic WTX-212C | Experimental | Participants will receive allogeneic WTX-212C via intravenous infusion in dose-escalation and dose-expansion cohorts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic WTX-212C | Drug | allogeneic WTX-212C is an investigational allogeneic engineered red blood cell-based injectable product administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) | Incidence of Dose-Limiting Toxicities (DLTs) | Within 21 days after the first dose |
| Incidence and Severity of Treatment-Related Adverse Events (TRAEs) | Incidence of Dose-Limiting Toxicities (DLTs) | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 21 days after the first dose |
| Pharmacokinetic Parameters (Cmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Immune Cell Subsets in Peripheral Blood | Quantitative and phenotypic analysis of peripheral blood immune cell subsets (e.g., T cells, B cells, NK cells) will be performed using flow cytometry to assess immunological changes following treatment. | From baseline up to 12 months |
| Exposure-Response Relationship |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Liu, PhD | Contact | 8613666601475 | Yangliuqq2003@163.com |
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This is a sequential assignment study consisting of a dose-escalation phase followed by a dose-expansion phase.
The dose-escalation phase will follow a standard 3+3 design with predefined dose levels. Dose escalation decisions will be based on the occurrence of dose-limiting toxicities (DLTs) observed during the first treatment cycle.
Upon identification of a tolerable dose level, one or more dose-expansion cohorts may be opened to further characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of allogeneic WTX-212C.
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Plasma pharmacokinetic parameters of allogeneic WTX-212C, including maximum observed concentration (Cmax）will be estimated using non-compartmental analysis methods. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | From first dose up to 12 months |
The relationship between pharmacokinetic exposure parameters (e.g., Cmax, AUC) and clinical outcomes (safety and efficacy endpoints) will be explored using descriptive and model-based analyses. |
| Up to 12 months |