Actively Recruiting
A First-in-human, Open-label, Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies in Patients With Advanced Solid Tumors
Led by Providence Health & Services · Updated on 2025-07-10
110
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating M3T01, a fully human monoclonal antibody targeting FasL, in people with metastatic or unresectable solid tumors. This first-in-human, open-label phase 1 trial aims to assess the safety, tolerability, and early signs of clinical effectiveness of M3T01 alone and combined with standard treatments like pembrolizumab, temozolomide, and FOLFOX chemotherapy. The study will determine the highest safe dose and recommended dose for further testing. The trial has two parts: Part 1 involves dose escalation with M3T01 alone or combined with pembrolizumab to find the maximum tolerated or administered dose. Part 2 expands the study to include up to 62 participants receiving M3T01 at the recommended dose with standard therapies, including chemoradiation for glioblastoma and combinations with pembrolizumab and FOLFOX for other cancers. Treatments are given via intravenous infusion every three weeks, alongside standard care treatments depending on the cancer type. Participants will undergo tumor biopsies, imaging, blood tests, and other assessments to monitor safety and effectiveness. The study will track treatment-related side effects, immune responses, drug levels, and tumor activity for up to four years. Regular evaluations will include performance status checks and organ function tests. Participants may also be monitored for long-term safety and response during and after treatment.
CONDITIONS
Brief Title
A Clinical Trial to Evaluate the Safety, Tolerability and Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Life expectancy of at least 12 weeks
- Provide written informed consent
- ECOG Performance Status of 0-1 for solid tumors other than glioblastoma
- Karnofsky Performance Status of 70% or higher for glioblastoma
- Provide tumor tissue from surgical or core needle biopsy (archival samples acceptable)
- Tumor must be accessible for biopsy unless authorized by sponsor (glioblastoma patients exempt)
- Histologically or cytologically confirmed metastatic or unresectable solid tumors with progression after standard systemic therapy
- Measurable disease per RECIST v1.1 or RANO 2.0 criteria
- Adequate organ function as defined by specific blood counts, liver and kidney tests
- Female subjects of reproductive potential must have negative pregnancy test and agree to effective contraception
- Male subjects with female partners of reproductive potential must agree to use effective contraception
- Agree not to donate sperm or eggs during and for 3 months after study drug administration
- Toxicities from prior anti-cancer therapy must have resolved to grade 1 or less, with some exceptions
You will not qualify if you...
- Treatment with anticancer therapy within 14 days or 5 half-lives before study start
- History of other active malignancy requiring treatment within 2 years, with some exceptions
- Significant cardiovascular conditions including heart failure class II or higher, low ejection fraction, certain arrhythmias, prolonged QTcF, recent heart attack or stroke
- CNS metastases or leptomeningeal carcinomatosis except stable treated brain metastases or limited asymptomatic metastases
- Treatment with immunosuppressive medications or high-dose corticosteroids
- Severe pulmonary diseases or current oxygen dependence
- History of stem cell or organ transplantation
- Autoimmune diseases requiring systemic immunosuppression within 2 years
- Immune-related adverse events causing treatment discontinuation from checkpoint inhibitors
- Severe hypersensitivity to monoclonal antibody infusions
- Major surgery within 4 weeks before first study dose
- Women who are pregnant or breastfeeding
- Active infections, with exceptions for controlled HIV, hepatitis B, and cured hepatitis C
- Ongoing drug or alcohol abuse
- Medical or psychiatric conditions that could affect study compliance
- Additional exclusions for newly diagnosed glioblastoma cohort including recurrent disease, incomplete resection, MRI contraindications, certain genetic mutations, unresolved CNS complications, and prior specific treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants receive M3T01 monotherapy or in combination with pembrolizumab and other systemic therapies. M3T01 is given by IV infusion every 3 weeks. Depending on cohort, participants may also receive pembrolizumab every 3 weeks, chemoradiation with temozolomide and radiation over 6 weeks followed by adjuvant temozolomide cycles, or FOLFOX chemotherapy on 14-day cycles.
Visits every 3 weeks for M3T01 infusion; additional visits depend on combination therapies
Trial Site Locations
Total: 1 location
1
Providence Portland Cancer Institute - Franz Clinic
Portland, Oregon, United States, 97213
Actively Recruiting
Research Team
T
Tara Foote, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
11
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