Study of MBRC-101 Antibody Drug Conjugate for Safety, Dosing, and Effectiveness in Adults with Advanced Solid Tumors Phase 11b Dose Finding and Phase 2 Treatment Evaluation

What this Trial Is About

Researchers are evaluating MBRC-101, an anti-EphA5 monomethyl auristatin E MMAE antibody drug conjugate, in patients with advanced metastatic solid tumors that have not responded to standard treatments. This first-in-human, open-label study includes Phase 1, Phase 1b, and Phase 2 phases to identify optimal dosing, assess safety, and evaluate preliminary clinical activity and efficacy in specific tumor types. The study is sponsored by MBrace Therapeutics and focuses on patients with no known beneficial standard care options. The study begins with Phase 1 dose escalation to find the maximum tolerated dose MTD and optimal biologically relevant doses OBRD of MBRC-101 in about 30 patients. Phase 1b involves dose expansion with approximately 60 patients across three cohorts with specific tumor types. After determining the recommended Phase 2 dose RP2D in Phase 1b, Phase 2 will enroll around 30 patients with a specific tumor type identified earlier to evaluate anti-tumor activity and safety. Safety is closely monitored throughout by a Safety Review Committee. Participants will undergo assessments including PET-CT, CT, and MRI scans evaluated by RECIST v1.1 criteria to measure response rates and disease control. Researchers will monitor treatment-emergent adverse events and dose-limiting toxicities over up to 24 months. Pharmacokinetic profiles and antibody incidence will be characterized. The study involves multiple treatment cycles with ongoing evaluations of overall response, progression-free survival, and overall survival to understand MBRC-101s effects and safety in this patient population.

Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors