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
Providence Health & Services
Summary
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.
Description
This is a first-in-human, phase I, open-label, dose escalation, dose expansion clinical trial designed to evaluate the safety, tolerability and preliminary clinical efficacy of M3T01 monotherapy and in combination with standard of care systemic therapies (including pembrolizumab, temozolomide, and FOLFOX) in subjects with advanced solid tumors. Within the Part 1 dose escalation stage of the study, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for M3T01 monotherapy and in combination with pembrolizumab will be determined. The recommended phase 2 dose (RP2D) will be determi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years. 2. Life expectancy ≥ 12 weeks. 3. Provision of written informed consent (see Section 16.1 and Appendix 18.5.5) for participation in the clinical trial. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1 for subjects with solid tumors other than glioblastoma. 5. Karnofsky Performance Status of ≥ 70% for subjects with glioblastoma. 6. Tumor tissue from a surgical or core needle biopsy must be provided to the sponsor (fine needle aspirate or cytology specimens are not acceptable). Archival formalin fixed paraffin embedded (FFPE) tis…
Interventions
- DrugM3T01
Subjects will be treated with M3T01 through an IV infusion over 1 hour given every 3 weeks.
- DrugPembrolizumab
Pembrolizumab will be given as standard of care to Cohort DL 5+ under Part 1 of the study. Subjects will receive 200 mg IV once every 3 weeks.
- RadiationChemoradiation
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.
- DrugFOLFOX regimen
FOLFOX will be given as standard of care on 14 day cycles. Subjects will receive oxaliplatin 85 mg/m2 IV on Day 1, leucovorin 400 mg/m2 IV on Day 1, fluorouracil 400 mg/m2 IV push on Day 1, and fluorouracil 1,200 mg/m2 IV continuous infusion on Days 1-2 every 14 days for up to 9 cycles.
Location
- Providence Portland Cancer Institute - Franz ClinicPortland, Oregon