Biohaven Therapeutics Ltd.
This is a Phase 1/2, first in human (FIH), open-label, multicenter study of BHV-1510 monotherapy and in Combination with Cemiplimab in participants with previously treated, advanced solid tumors.
This is a Phase 1/2, first in human (FIH), open-label, multicenter study of BHV-1510, a Trop-2 directed antibody-drug conjugate (ADC), in participants with previously treated, advanced solid tumors. The study comprises 2 parts: a Phase 1 Dose Escalation and a Phase 2 Dose Expansion. The Phase 1 will investigate the safety and tolerability of BHV-1510 given in monotherapy and given in combination with cemiplimab and identify one or more recommended doses for expansion (RDEs) and the maximum-tolerated dose (MTD) (if one exists). Once the RDE has been established, Phase 2 will open to investigate…
Key Inclusion Criteria: * Male or female participants aged ≥18 years. * Unresectable, incurable, locally advanced or metastatic epithelial-origin solid tumor that is refractory to standard therapies, or has no approved standard therapies, or no approved standard therapies at its current treatment stage. If applicable to the tumor type, participants must have received platinum-based chemotherapy, standard of care immunotherapy, and standard of care targeted therapies. * Measurable disease (per RECIST 1.1). * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. * Participants ha…
BHV-1510 will be administered on Day 1 every 3 weeks
cemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks
BHV-1510 will be administered on Day 1 every 2 weeks
BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks
cemiplimab (350mg) will be administered as an IV infusion on Day 1 and Day 8 every 3 weeks