Actively Recruiting
A Clinical Trial to Evaluate the Safety, Tolerability and Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies
Led by Providence Health & Services · Updated on 2025-07-10
110
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Written informed consent provided
- ECOG Performance Status of 0-1 for solid tumors other than glioblastoma
- Karnofsky Performance Status of 70% or higher for glioblastoma patients
- Provide tumor tissue from surgical or core needle biopsy or acceptable archival tissue
- Tumor accessible for biopsy during treatment or authorization from sponsor if not accessible (except glioblastoma patients)
- Histologically or cytologically confirmed metastatic or unresectable solid tumors with disease progression after standard therapy
- Measurable disease per RECIST v1.1 for solid tumors other than glioblastoma; glioblastoma measurable per RANO 2.0 in Part 1
- Adequate organ function including specific blood counts and liver, kidney function tests as defined
- Female participants of reproductive potential must have a negative pregnancy test and agree to use effective contraception
- Male participants with partners of reproductive potential must agree to use effective contraception
- Agree not to donate sperm or eggs during study and for 3 months after last dose
- Toxicities from prior cancer therapy resolved to grade 1 or less except for certain conditions
You will not qualify if you...
- Received anticancer therapy within 14 days or 5 half-lives before study start (palliative radiation allowed if completed 14 days prior)
- History of other active malignancies requiring treatment within 2 years, with some exceptions
- Significant cardiovascular conditions including congestive heart failure class II or higher, reduced heart function, recent arrhythmias or heart events
- CNS metastases or leptomeningeal carcinomatosis except stable or limited brain metastases
- Use of immunosuppressive medications or high-dose corticosteroids
- History of severe pulmonary diseases or oxygen dependency
- History of organ or stem cell transplants
- Autoimmune diseases requiring systemic immunosuppression within 2 years
- History of immune-related adverse events from checkpoint inhibitors requiring discontinuation
- Severe hypersensitivity to monoclonal antibody infusions
- Major surgery within 4 weeks before first treatment
- Pregnant or breastfeeding women
- Active infections unless specific controlled infections (HIV, hepatitis B or C) meeting criteria
- Ongoing drug or alcohol abuse
- Medical, psychiatric, or social conditions jeopardizing study compliance
- Additional exclusion criteria for glioblastoma cohort including recurrent disease, biopsy only, MRI contraindications, certain mutations, unresolved CNS hemorrhage, prior treatments like wafer implant or Tumor Treating Fields
AI-Screening
AI-Powered Screening
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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
CONTACT
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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