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NCT Number: NCT07556653

Allogeneic WTX-212C in Advanced Solid Tumors

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Zhejiang Provincial Hospital

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Yang Liu, PhD

CONTACT

[email protected]

8613666601475

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

allogeneic WTX-212C

Drug

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

Primary outcomes

  1. Incidence of Dose-Limiting Toxicities (DLTs)

    Time frame: Within 21 days after the first dose

    Incidence of Dose-Limiting Toxicities (DLTs)

  2. Incidence and Severity of Treatment-Related Adverse Events (TRAEs)

    Time frame: Up to 12 months

    Incidence of Dose-Limiting Toxicities (DLTs)

Secondary outcomes

  1. Maximum Tolerated Dose (MTD)

    Time frame: Within 21 days after the first dose

    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.

  2. Pharmacokinetic Parameters (Cmax)

    Time frame: From first dose up to 12 months

    Plasma pharmacokinetic parameters of allogeneic WTX-212C, including maximum observed concentration (Cmax）will be estimated using non-compartmental analysis methods.

  3. Objective Response Rate (ORR)

    Time frame: Up to 12 months

    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.

  4. Disease Control Rate (DCR)

    Time frame: Up to 12 months

    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.

  5. Progression-Free Survival (PFS)

    Time frame: Up to 12 months

    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.

  6. Incidence of Anti-Drug Antibodies (ADA)

    Time frame: From baseline up to 12 months

    The incidence of anti-drug antibodies (ADA) against allogeneic WTX-212C will be assessed using validated immunoassays.

  7. Pharmacokinetic Parameters (AUC)

    Time frame: From first dose up to 12 months

    Plasma pharmacokinetic parameters of allogeneic WTX-212C，area under the concentration-time curve (AUC), will be estimated using non-compartmental analysis methods.

  8. Pharmacokinetic Parameters (Tmax)

    Time frame: From first dose up to 12 months

    Plasma pharmacokinetic parameters of allogeneic WTX-212C, time to maximum concentration (Tmax) will be estimated using non-compartmental analysis methods.

  9. Pharmacokinetic Parameters (T1/2)

    Time frame: From first dose up to 12 months

    Plasma pharmacokinetic parameters of allogeneic WTX-212C, and terminal elimination half-life (t1/2) will be estimated using non-compartmental analysis methods.

Other outcomes

  1. Changes in Immune Cell Subsets in Peripheral Blood

    Time frame: From baseline up to 12 months

    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.

  2. Exposure-Response Relationship

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Liu, PhD

CONTACT

[email protected]

8613666601475

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Collaborators

  • First People's Hospital of Hangzhou
  • Westlake Therapeutics

Registry information

Official study 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

Acronym: WTX-212C-IIT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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