A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiohaven Therapeutics Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Women who are pregnant or lactating.
Clinically significant intercurrent disease.
Has symptomatic brain metastases or has had any radiation or surgery for brain metastases within 4 weeks of C1D1.
Has clinically significant corneal disease.
Trial design
Treatments tested in this trial
- BHV-1510
- Cemiplimab
- BHV-1510
- BHV-1510
- Cemiplimab
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov