Clinical trial · Interventional
Allogeneic WTX-212C in Advanced Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic WTX-212C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Allogeneic WTX-212C
- description
- Participants will receive allogeneic WTX-212C via intravenous infusion in dose-escalation and dose-expansion cohorts.
- interventionNames
- Drug: allogeneic WTX-212C
Primary outcomes (2)
- measure
- Incidence of Dose-Limiting Toxicities (DLTs)
- timeFrame
- Within 21 days after the first dose
- description
- Incidence of Dose-Limiting Toxicities (DLTs)
- measure
- Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
- timeFrame
- Up to 12 months
- description
- Incidence of Dose-Limiting Toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available