M3T01 for Cancer

Overseen By Tara Foote, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Providence Health & Services

Must not be taking: Immunosuppressives, Corticosteroids

Disqualifiers: Active infection, Severe pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have had anticancer therapy within 14 days or 5 half-lives of starting the trial. It also excludes those on certain immunosuppressive medications and corticosteroids above a certain dose.

Research Team

Rom Leidner, MD

Principal Investigator

Providence Health & Services

Eligibility Criteria

This trial is for individuals with metastatic or unresectable solid tumors. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

Life expectancy ≥ 12 weeks

Provision of written informed consent for participation in the clinical trial

I am fully active or can carry out light work despite my solid tumor.

Exclusion Criteria

I have not had any other cancer besides this one in the last 2 years.

I do not have serious heart conditions.

I haven't taken immune-weakening drugs for an autoimmune disease in the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD) for M3T01 monotherapy and in combination with pembrolizumab

21 days per dose level

Multiple visits for dose administration and monitoring

Dose Expansion

Administration of M3T01 at the recommended phase 2 dose (RP2D) in combination with standard of care systemic therapies

Varies by treatment arm

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Regular follow-up visits

Treatment Details

Interventions

• M3T01
• Pembrolizumab

Trial Overview The study tests M3T01, a new monoclonal antibody, alone and combined with Pembrolizumab and other treatments like chemoradiation and the FOLFOX regimen. It's an early-phase trial to find safe dosage levels and see if it works against solid tumors.

Participant Groups

Group I: Part 2C: Second-line treatment for recurrent/metastatic HNSCC Experimental Treatment 2 Interventions

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.

Group II: Part 2B: First-line tx for unresectable/metastatic HER2- esophageal, GEJ, or gastric adenocarcinoma. Experimental Treatment 3 Interventions

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.

Group III: Part 2A: Newly diagnosed glioblastoma with unmethylated MGMT promoter Experimental Treatment 2 Interventions

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.

Group IV: Part 1B: DL 8 Experimental Treatment 2 Interventions

M3T01 800 mg in combination with pembrolizumab 200 mg.

Group V: Part 1B: DL 7 Experimental Treatment 2 Interventions

M3T01 600 mg in combination with pembrolizumab 200 mg.

Group VI: Part 1B: DL 6 Experimental Treatment 2 Interventions

M3T01 400 mg in combination with pembrolizumab 200 mg.

Group VII: Part 1A: DL 5 Experimental Treatment 1 Intervention

M3T01 800 mg as monotherapy.

Group VIII: Part 1A: DL 4 Experimental Treatment 1 Intervention

M3T01 600 mg as monotherapy.

Group IX: Part 1A: DL 3 Experimental Treatment 1 Intervention

M3T01 400 mg as monotherapy.

Group X: Part 1A: DL 2 Experimental Treatment 1 Intervention

M3T01 200 mg as monotherapy.

Group XI: Part 1A: DL 1 Experimental Treatment 1 Intervention

M3T01 100 mg as monotherapy.

Who Is Running the Clinical Trial?

Providence Health & Services

Lead Sponsor

Trials

131

Recruited

827,000+