Allogeneic WTX-212C in Advanced Solid Tumors

ConditionAdvanced Solid Tumors

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorZhejiang Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years

Histologically or cytologically confirmed advanced solid tumors

At least one measurable lesion per RECIST 1.1

ECOG performance status ≤1

Disqualifiers

Uncontrolled serious medical conditions

Active or uncontrolled infections

Symptomatic or unstable CNS metastases

History of severe hypersensitivity to biologic agents

Trial design

Design model

Sequential

Treatments tested in this trial

allogeneic WTX-212C
Drug
allogeneic WTX-212C is an investigational allogeneic engineered red blood cell-based injectable product administered intravenously.

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: Experimental: Allogeneic WTX-212CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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.

Time frame

From baseline up to 12 months

Exposure-Response Relationship

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.

Time frame

Up to 12 months

Sponsors and contacts

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Zhejiang Provincial People's Hospital

Lead sponsor

Westlake Therapeutics

Collaborator

First People's Hospital of Hangzhou

Collaborator

Source ClinicalTrials.gov

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