NCT06384807

A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors

A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of BHV-1510 (Previously PBI-410) as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Biohaven Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 the preliminary efficacy of BHV-1510 in signal-finding expansion cohorts.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	BHV-1510	BHV-1510 will be administered on Day 1 every 3 weeks
DRUG	Cemiplimab	cemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks
DRUG	BHV-1510	BHV-1510 will be administered on Day 1 every 2 weeks
DRUG	BHV-1510	BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks
DRUG	Cemiplimab	cemiplimab (350mg) will be administered as an IV infusion on Day 1 and Day 8 every 3 weeks

Timeline

• Start date: 2024-04-22
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2024-04-25
• Last updated: 2026-03-11

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study