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drugset / Trial / NCT06719362

A Clinical Trial to Evaluate the Safety, Tolerability and Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies

NCT06719362 ↗

Phase 1 Recruiting 110 enrolled Providence Health & Services
Non-randomizedSequentialOpen-labelTreatment

Summary

Phase 1 first-in-human, open-label, dose-escalation (3 + 3), dose-expansion clinical trial to evaluate the safety, tolerability and preliminary clinical efficacy of M3T01 (fully human IgG4/kappa monoclonal antibody targeting FasL) in subjects with metastatic or unresectable solid tumors.

Timeline

Start
2025-06-17
Primary completion
2028-02
Completion
2030-02

Drugs

EvaluationDrugModalityDoseRoute
Subject M3T01 Monoclonal antibody 100 mg Intravenous
Subject M3T01 Monoclonal antibody 200 mg Intravenous
Subject M3T01 Monoclonal antibody 400 mg Intravenous
Subject M3T01 Monoclonal antibody 600 mg Intravenous
Subject M3T01 Monoclonal antibody 800 mg Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background fluorouracil Small molecule 1200 mg/m2 Intravenous

Indications

cancer