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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Providence Health & Services
Study ID
NCT06719362
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M3T01 — DRUG
    Subjects will be treated with M3T01 through an IV infusion over 1 hour given every 3 weeks.
  • Pembrolizumab — DRUG
    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.
  • Chemoradiation — RADIATION
    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.
  • FOLFOX regimen — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 17, 2025
Status verified
Jul 2025
Primary completion
Feb 29, 2028
Completion
Feb 28, 2030

Study Design

Enrollment
110 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: DL 1
    M3T01 100 mg as monotherapy.
  • Experimental: Part 1A: DL 2
    M3T01 200 mg as monotherapy.
  • Experimental: Part 1A: DL 3
    M3T01 400 mg as monotherapy.
  • Experimental: Part 1A: DL 4
    M3T01 600 mg as monotherapy.
  • Experimental: Part 1A: DL 5
    M3T01 800 mg as monotherapy.
  • Experimental: Part 1B: DL 6
    M3T01 400 mg in combination with pembrolizumab 200 mg.
  • Experimental: Part 1B: DL 7
    M3T01 600 mg in combination with pembrolizumab 200 mg.
  • Experimental: Part 1B: DL 8
    M3T01 800 mg in combination with pembrolizumab 200 mg.
  • Experimental: Part 2A: Newly diagnosed glioblastoma with unmethylated MGMT promoter
    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.
  • Experimental: Part 2B: First-line tx for unresectable/metastatic HER2- esophageal, GEJ, or gastric adenocarcinoma.
    Subjects with unresectable or metastatic HER2 negative esophageal, gastroesophageal (GEJ), or gastric adenocarcinoma without prior systemic therapy in the metastatic setting will be treated with M3T01 at the RPD2 in combination with standard of care pembrolizumab plus FOLFOX chemotherapy.
  • Experimental: Part 2C: Second-line treatment for recurrent/metastatic HNSCC
    Subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have developed disease progression after first-line systemic therapy with an anti-PD-1-based regimen in the recurrent or metastatic setting will be treated with M3T01 at the RP2D in combination with pembrolizumab 200 mg IV every 3 weeks for up to 2 years.

Primary Outcome Measure

Treatment-emergent adverse events [ Time Frame: 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Portland Cancer Institute - Franz ClinicPortlandOregon97213
Tara Foote, RN
[email protected]
503-215-1979
Rom Leidner, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Portland, OR

By research site
Providence Portland Cancer Institute - Franz Clinic· Portland, OR

Related Studies