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

NCT06719362 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-07-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Rom Leidner, MD · Providence Health & Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2028-02-29
Completion
2030-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719362 on ClinicalTrials.gov