NCT06719362

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

A First-in-human, Open-label, Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a first-in-human, phase I, open-label, dose escalation, dose expansion clinical trial designed to evaluate the safety, tolerability and preliminary clinical efficacy of M3T01 monotherapy and in combination with standard of care systemic therapies (including pembrolizumab, temozolomide, and FOLFOX) in subjects with advanced solid tumors. Within the Part 1 dose escalation stage of the study, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for M3T01 monotherapy and in combination with pembrolizumab will be determined. The recommended phase 2 dose (RP2D) will be determined based upon available pharmacokinetic, pharmacodynamic, and preliminary clinical efficacy data and will be equal to or lower than the MTD. M3T01 will be administered at the RP2D in combination with standard of care systemic therapies (including pembrolizumab, temozolomide, and FOLFOX) in the Part 2 dose expansion stage of the clinical trial. Up to 48 subjects will be enrolled in the Part 1 dose escalation stage of the study (depending on observed toxicity and when the MTD/MAD is reached). The Part 2 dose expansion portion of the study will enroll up to 62 subjects.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	M3T01	Subjects will be treated with M3T01 through an IV infusion over 1 hour given every 3 weeks.
DRUG	Pembrolizumab	Pembrolizumab will be given as standard of care to Cohort DL 5+ under Part 1 of the study. Subjects will receive 200 mg IV once every 3 weeks.
RADIATION	Chemoradiation	Subjects will be treated with standard of care chemoradiation therapy consisting of TMZ 75 mg/m2 daily with concurrent radiation therapy (60 Gy administered over 6 weeks). Following chemoradiation therapy, subjects will have a 4-week break from TMZ before starting standard adjuvant TMZ 150-200 mg/m2 days 1-5 of 28-day cycles for 6 cycles. Subjects will be treated with M3T01 at the RP2D through an IV infusion every 3 weeks that will begin concurrently with chemoradiation therapy.
DRUG	FOLFOX regimen	FOLFOX will be given as standard of care on 14 day cycles. Subjects will receive oxaliplatin 85 mg/m2 IV on Day 1, leucovorin 400 mg/m2 IV on Day 1, fluorouracil 400 mg/m2 IV push on Day 1, and fluorouracil 1,200 mg/m2 IV continuous infusion on Days 1-2 every 14 days for up to 9 cycles.

Timeline

• Start date: 2025-06-17
• Primary completion: 2028-02-01
• Completion: 2030-02-01
• First posted: 2024-12-05
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study