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BHV-1510

Phase 1

Solid Tumor | Small molecule | Oncology |Biohaven Ltd.|Last Updated: Mar 11, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06384807A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid TumorsPHASE1 RECRUITING 500 — — Apr 22, 2024Feb 1, 2028Mar 11, 202617 United States
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Study Endpoints
Primary Endpoints
Phase 1: Number of patients with adverse events (AEs)
Through study completion, estimated as an average of 47 months

Description: Incidence and severity of AEs, serious adverse events (SAEs) and dose limiting toxicities (DLTs). Severity of AEs will be assessed according to the NCI CTCAE v5.0. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.

Phase 1: Recommended doses or schedules for expansion (RDEs) and maximum tolerated dose (MTD)
Approximately 15 months

Based on tolerability and preliminary antitumor activity. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.

Phase 2: Objective Response Rate (ORR) for BHV-1510 for monotherapy and in combination with cemiplimab
Through study completion, estimated as an average of 47 months

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.

Phase 2: Number of patients with AEs for BHV-1510 for monotherapy and in combination with cemiplimab
Through study completion, estimated as an average of 47 months

Incidence and severity of AEs, SAEs and DLTs. Severity of AEs will be assessed according to the NCI CTCAE v5.0

Phase 2: Duration of Response (DoR) for BHV-1510 for monotherapy and in combination with cemiplimab
Through study completion, estimated as an average of 47 months

Assessed by RECIST v 1.1

Secondary Endpoints
Phase 1 and 2: Maximum Plasma Concentration (Cmax) of BHV-1510, total antibody and payload (BHC-0080269)
Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Area Under the Concentration versus time Curve from the end of infusion to the last measurable concentration (AUClast) of BHV-1510, total antibody and payload
Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Area Under the Concentration versus time curve extrapolated to infinity (AUCinf) of BHV-1510, total antibody and payload
Up to 8 timepoints, but not exceeding, 22 days in Cycle 1
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BHV-1510 Monotherapy Dose EscalationEXPERIMENTAL -
BHV-1510 in combination with Cemiplimab dose escalationEXPERIMENTAL -
Interventions
NameTypeDescription
BHV-1510DRUGBHV-1510 will be administered on Day 1 every 3 weeks
CemiplimabDRUGcemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

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 s...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06384807primaryCompletionDate: changed
LOWMay 24, 2026NCT06384807studyFirstPostDate: changed