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A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of MIL93 in Advanced or Metastatic Solid Tumors.
MIL93 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open label Phase I study to evaluate safety, tolerability, pharmacokinetics and efficacy of MIL93 in Advanced or Metastatic solid tumors.
Details
| Lead sponsor | Beijing Mabworks Biotech Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 228 |
| Start date | 2021-04-21 |
| Completion | 2025-08 |
Conditions
- Advanced Malignancies
Interventions
- Recombinant Humanized Monoclonal Antibody MIL93
Primary outcomes
- Percentage of Participants with Adverse Events — up to 1year after enrollment
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
Countries
China