Allogeneic WTX-212C in Advanced Solid Tumors

Trial statusNot yet recruiting
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

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

Treatments tested in this trial

  • allogeneic WTX-212C

Treatment groups

24 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Zhejiang Provincial People's Hospital

Lead sponsor

Westlake Therapeutics

Collaborator

First People's Hospital of Hangzhou

Collaborator