Allogeneic WTX-212C in Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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

Primary outcome measure(s)

• Incidence of Dose-Limiting Toxicities (DLTs) — Within 21 days after the first dose
  Incidence of Dose-Limiting Toxicities (DLTs)
• Incidence and Severity of Treatment-Related Adverse Events (TRAEs) — Up to 12 months
  Incidence of Dose-Limiting Toxicities (DLTs)

Trial sites (1)

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