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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called M3T01 for individuals with certain types of difficult-to-treat cancers that have spread or cannot be surgically removed. Researchers aim to assess the safety and effectiveness of this treatment, both alone and in combination with other cancer drugs like pembrolizumab (also known as KEYTRUDA or MK-3475). The trial is open to individuals with specific cancers, such as glioblastoma, esophageal, gastric, and head and neck cancers, who have not responded to other treatments. Those who have experienced disease progression after standard therapies and have a measurable tumor may be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found pembrolizumab, one of the drugs used in this trial, to be generally safe. This conclusion comes from data on 2,799 patients across various clinical trials. Most participants tolerated it well, though some experienced side effects, which were usually mild, such as fatigue or rash.

For M3T01, this trial marks its first test in humans. As a Phase 1 trial, the primary goal is to assess its safety and determine the correct dosage. Researchers are still learning about its tolerability.

While human data for M3T01 is limited, pembrolizumab's safety record provides some context. However, the combination of the two drugs might produce different effects. Prospective participants should understand that a significant focus of the study is to evaluate the safety of M3T01. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about M3T01 because it offers a unique approach to cancer treatment by potentially enhancing the immune system's ability to target tumors. Unlike many standard cancer treatments that rely on chemotherapy or radiation alone, M3T01 is being tested both as a monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor. This combination aims to boost anti-tumor activity, potentially leading to better outcomes for patients with various cancer types. Additionally, M3T01's versatility in dosage and combination allows it to be tailored for specific cancer conditions, which could improve effectiveness and reduce side effects compared to traditional treatments.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that M3T01, a monoclonal antibody treatment, is under study for its potential to treat cancer. Although direct evidence on M3T01's effectiveness in humans remains limited, it targets a protein called FasL, which plays a role in the immune system and the death of cancer cells. In this trial, some participants will receive M3T01 as monotherapy, while others will receive it in combination with pembrolizumab, a well-known cancer treatment. Early studies of similar treatment combinations have shown that 53% of patients responded, with some experiencing complete or partial improvement. These findings suggest that M3T01, especially when combined with pembrolizumab, might enhance the body's immune response against cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Rom Leidner, MD

Principal Investigator

Providence Health & Services

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06719362

Study Details | NCT06719362 | A Clinical Trial to Evaluate ... A Clinical Trial to Evaluate the Safety, Tolerability and Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic ...

2. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06719362/

Trial | NCT06719362 ... Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies ... efficacy data and will be equal to or lower than the MTD.

3. withpower.com withpower.com/trial/m3t01-for-cancer-68a9a

M3T01 for Cancer · Recruiting Participants for Phase ... This Phase 1 medical study run by Providence Health & Services is evaluating whether M3T01 will have tolerable side effects & efficacy for patients with ...

4. synapse.patsnap.com synapse.patsnap.com/drug/db2dc6a3f2054ad191af00e619398eb8

M3T01 - Drug Targets, Indications, Patents Results: This meta-analysis included six trials, including 238 people with CC. ... Conclusions: This meta-analysis demonstrates that camrelizumab is efficacious ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12184348/

A real-world study on the efficacy and safety of low-dose ... Low-dose PD-1 monoclonal antibody therapy demonstrated comparable efficacy to standard-dose therapy with a lower incidence of severe irAEs in combination ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11227881/

Safety profile of pembrolizumab monotherapy based on an ... Pembrolizumab has a manageable safety profile as described in its label, which was primarily based on 2799 patients who participated in clinical trials for ...

7. biotechhunter.com biotechhunter.com/trials/NCT06719362

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