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.
Age ≥ 18 years.
Life expectancy ≥ 12 weeks.
Provision of written informed consent (see Section 16.1 and Appendix 18.5.5) for participation in the clinical trial.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1 for subjects with solid tumors other than glioblastoma.
Treatment with anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of cycle 1 day 1. Palliative radiation therapy to a non-CNS metastasis is permitted if completed at least 14 days prior to cycle 1 day 1.
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.
New York Heart Association (NYHA) congestive heart failure class ≥ II.
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Treatment groupsSee each treatment group below.