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BHV-1530

Phase 1

Solid Tumor | Small molecule | Oncology |Biohaven Ltd.|Last Updated: May 13, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment95
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06874335A Phase 1 Study of BHV-1530 in Advanced Solid TumorsPHASE1 RECRUITING 95Mar 20, 2025Mar 1, 2029May 13, 202613 United States
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Study Endpoints
Primary Endpoints
Dose-escalation and Dose-expansion Cohorts: Number of patients with AEs
Through study completion, estimated as an average of 48 months

Incidence and severity of treatment emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs) and serious adverse events (SAEs)

Dose-confirmation Cohorts: Recommended dose of BHV-1530 for later phase trials
Through study completion, estimated as an average of 48 months

Incidence and severity of adverse events (AEs) and SAEs, dose reductions during treatment, study discontinuation rates due to TEAEs, and signals of antitumor activity

Secondary Endpoints
Dose-escalation and Dose-expansion Cohorts: Clinical Benefit Rate (CBR)
Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Objective Response Rate (ORR)
Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Disease Control Rate (DCR)
Through study completion, estimated as an average of 48 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BHV-1530 MonotherapyEXPERIMENTAL -
Interventions
NameTypeDescription
BHV-1530DRUGBHV-1530 will be administered as an IV infusion on Day 1 of each 21-day cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Signed, written Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent 2. Age greater than or equal to 18 years 3. Participants consent to provide tumor tissue collected prior to study treatment, preferably from a biopsy performed after ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06874335primaryCompletionDate: changed
LOWMay 24, 2026NCT06874335studyFirstPostDate: changed