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M3T01 for Advanced Solid Tumors

This study is testing a new drug called M3T01, alone and in combination with other standard treatments like pembrolizumab, chemoradiation, or FOLFOX, for people with advanced solid tumors. Researchers want to see how safe M3T01 is, what side effects it might cause, and if it helps to treat the cancer. M3T01 is a type of monoclonal antibody, which is a lab-made protein that can target specific things in the body. You may be able to join if you are at least 18 years old, have a life expectancy of at least 12 weeks, and have advanced solid tumors. The study will look at side effects for up to 4 years.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know which treatment you are receiving. It will enroll up to 110 participants to find the best dose of M3T01.
What's involved
You would receive M3T01 through an IV infusion every 3 weeks. Depending on the study part, you might also receive pembrolizumab, chemoradiation, or FOLFOX, each given on a specific schedule.
Compensation
Not stated in the trial record.
Follow-up
The study will track treatment-emergent adverse events and serious adverse events for up to 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06719362

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Providence Health & Services
~110 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:M3T01PembrolizumabChemoradiationFOLFOX regimen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment-emergent adverse events
Measured over 4 years
+3 more outcomes measured

Conditions

Advanced Solid Tumors

Explore related trials

GlioblastomaSolid Neoplasm

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Rom Leidner, MD · PRINCIPAL_INVESTIGATOR · Providence Health & Services

Who to contact

Tara Foote, RN
[email protected]
503-215-1979
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Subjects with solid tumors other than glioblastoma must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Subjects with glioblastoma: Part 1: must have measurable disease per Response Assessment in Neuro-Oncology (RANO 2.0); Part 2: measurable disease at baseline is not required as these subjects will have undergone maximal safe resection prior to enrollment. 10. Adequate organ function as defined by the following:
Absolute neutrophil count (ANC) ≥ 1.2 x 109/L.
Hemoglobin ≥ 9.0 g/dL (without a blood transfusion 2 weeks prior to the hemoglobin measurement).
Platelet count ≥ 100 x 109/L (without a platelet transfusion 2 weeks prior to the platelet measurement).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
Total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for subjects with Gilbert's syndrome).
International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (unless the subject is being treated with anticoagulant medication).
Serum albumin ≥ 2.8 g/dL.
Creatinine clearance (measured or calculated) ≥ 30 mL/min. 11. Female subjects of reproductive potential who are sexually active with a male partner must:
Have a negative serum beta-human chorionic gonadotropin (β-HCG) test within 3 days of cycle 1 day 1.
Agree to use highly effective contraceptive measures (as defined in protocol) from the time of enrollment through 3 months after the last dose of study drug in the clinical trial.
Female subjects are considered to be of non-reproductive potential if they: have been amenorrheic for greater than 1 year or have undergone surgical sterilization through tubal ligation, oophorectomy or hysterectomy. 12. Male subjects with a female partner of reproductive potential must agree to use highly effective contraception (as defined in protocol) from the time of enrollment through 3 months after the last dose of study drug administration. 13. Subjects must agree to not donate sperm or eggs (ova, oocytes) for the purpose of reproduction from the time of enrollment through 3 months after the last dose of study drug administration. 14. Toxicities from prior anti-cancer therapy must have resolved to grade ≤ 1.
Exceptions include vitiligo, endocrinopathies managed with hormone replacement therapy, alopecia, and grade 2 neuropathy or hearing loss.

Exclusion

Early-stage/localized tumors that have received definitive/curative treatment and have low risk of recurrence (including but not limited to cutaneous squamous cell or basal cell carcinoma, in situ cervical or bladder cancer, and early-stage prostate cancer).
Early-stage prostate cancer in which observation without treatment is recommended. 3. Clinically significant cardiovascular conditions as defined by the following:
New York Heart Association (NYHA) congestive heart failure class ≥ II.
Left ventricular ejection fraction ≤ 50%.
Clinically significant cardiac arrhythmia requiring treatment within 3 months of enrollment. Subjects with cardiac arrhythmias on stable management for over 3 months prior to enrollment are permitted.
Prolonged QTcF interval \> 480 ms.
Myocardial infarction, stroke, or pulmonary embolism within 3 months of enrollment. 4. CNS metastases or leptomeningeal carcinomatosis (applicable to subjects with solid tumors other than glioblastoma). Subjects with brain metastases are eligible for participation if one of the following criteria are met:
CNS metastases have been treated with surgical resection or radiation therapy and have remained stable for at least 4 weeks (repeat imaging required at least 4 weeks following resection or last radiation therapy) prior to cycle 1 day 1.
The subject is neurologically asymptomatic and there are ≤ 4 CNS metastases no larger than 1 cm. 5. Treatment with immunosuppressive medications.
History of interstitial lung disease, non-infectious pneumonitis (including immune checkpoint inhibitor induced pneumonitis), or pulmonary fibrosis.
Currently dependent on supplemental oxygen. 7. History of allogeneic stem cell or solid organ transplantation. 8. History of autoimmune disease that required systemic immunosuppressive therapy within 2 years of enrollment. Subjects with autoimmune diseases managed with hormone replacement or topical therapies are eligible. 9. History of an immune-mediated adverse event from treatment with an immune checkpoint inhibitor that resulted in treatment discontinuation.
Subjects with human immunodeficiency virus (HIV) are eligible for participation if the following criteria are met: CD4+ T cell count ≥350 cells/µL, No history of AIDS-defining opportunistic infections within 12 months of enrollment, Subjects must be on antiretroviral therapy for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
Subjects with chronic hepatitis B (HBV) who are on suppressive antiviral therapy prior to enrollment are eligible. Subjects with chronic HBV who are not eligible for treatment with suppressive antiviral therapy are ineligible.
Subjects with a history of hepatitis C (HCV) infection who have completed curative antiviral treatment and have an HCV viral load below the limit of quantification are eligible. 14. Ongoing drug or alcohol abuse at the time of enrollment. 15. Any medical or psychiatric illness or social circumstance that could jeopardize compliance with the protocol directed treatment and safety assessments.

What this trial measures

  • Treatment-emergent adverse events4 years

    Safety parameters including clinical assessments, vital signs, laboratory testing, and electrocardiograms (ECG) will be used to assess treatment-emergent adverse events (TEAE). Adverse events will be graded using the NCI-CTCAE v5.0. Investigators will determine relatedness of all treatment emergent adverse events (TEAE) to the investigational agent(s).

  • Dose-limiting toxicities21 days after C1D1

    The DLT evaluation period will be defined as the first 21 days after infusion of M3T01 as monotherapy or in combination with other systemic therapies (including pembrolizumab, temozolomide, and FOLFOX). Site investigators will grade toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  • Serious adverse events4 years

    Clinical assessments, vital signs, laboratory testing, and electrocardiograms (ECG) will be used to assess serious adverse events (SAE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  • Immune-related adverse events4 years

    Clinical assessments, vital signs, laboratory testing, and electrocardiograms (ECG) will be used to assess immune-related adverse events (irAE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.