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
Locations
Sponsors and collaborators
Zhejiang Provincial People's Hospital
Lead sponsor
Westlake Therapeutics
Collaborator
First People's Hospital of Hangzhou
Collaborator