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BHV-1530

Phase 1

Solid Tumor | Small molecule | Oncology |Biohaven Ltd.|Last Updated: Jul 9, 2026

Target and mechanism

Molecular targetFGFR3
Target classReceptor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

BHV-1530 · 1 trial · 1 indication

Phase 1 1
NCT06874335A Phase 1 Study of BHV-1530 in Advanced Solid TumorsSolid Tumor
RECRUITING140 Analytics
PHASE1RECRUITING
A Phase 1 Study of BHV-1530 in Advanced Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose-escalation and Dose-expansion Cohorts: To determine the safety profile, maximum tolerable dose (MTD), minimally reproducible active dose (MRAD), and recommended dose range (RDR) of BHV-1530 monotherapy and BHV-1530 in combination with cemiplimab
Through study completion, estimated as an average of 48 months

Incidence and severity of TEAEs, including DLTs, SAEs and change from baseline for laboratory values, electrocardiograms (ECGs), vital signs, and physical exams to determine the safety profile, MTD, MRAD and RDR of BHV-1530 monotherapy and in combination with cemiplimab.

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

Incidence and severity of treatment-emergent AEs and SAEs, changes between baseline and postbaseline in laboratory values, ECGs, vital signs, and physical exams.

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

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BHV-1530 MonotherapyEXPERIMENTAL -
Experimental: BHV-1530 in combination with CemiplimabEXPERIMENTAL -

Interventions

NameTypeDescription
BHV-1530DRUGBHV-1530 will be administered as an IV infusion on Day 1 of each 21-day cycle
CemiplimabDRUGcemiplimab (350 mg) will be administered as an IV infusion on Day 1 of each 21-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Recent Changes (Last 90 Days)

MEDIUMJul 9, 2026NCT06874335Enrollment: 95 → 140
MEDIUMJul 9, 2026NCT06874335Enrollment: 95 → 140
LOWMay 26, 2026NCT06874335primaryCompletionDate: changed
LOWMay 24, 2026NCT06874335studyFirstPostDate: changed

Frequently asked questions about BHV-1530

What is BHV-1530 used for in solid tumors?

BHV-1530 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development as a potential therapy for advanced solid tumors. The drug is not yet approved and is being studied in a clinical trial setting to evaluate its safety and efficacy.

What does BHV-1530 target?

BHV-1530 targets FGFR3, a receptor tyrosine kinase. By targeting FGFR3, BHV-1530 is designed to interfere with signaling pathways that may drive tumor growth in certain solid tumors. This mechanism is being investigated in early-stage clinical trials for patients with advanced solid tumors.

Who is developing BHV-1530?

BHV-1530 is being developed by Biohaven Ltd., a biopharmaceutical company. Biohaven is conducting clinical trials to evaluate the safety and efficacy of BHV-1530 in patients with advanced solid tumors. The company is listed on the stock exchange under the ticker symbol BHVN.

What phase is BHV-1530 in?

BHV-1530 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to assess the drug's safety, tolerability, and preliminary efficacy in advanced solid tumors.

What clinical trials is BHV-1530 in?

BHV-1530 is being studied in a Phase 1 clinical trial with the identifier NCT06874335. This trial, titled 'A Phase 1 Study of BHV-1530 in Advanced Solid Tumors,' is currently recruiting participants in the United States. The study aims to enroll approximately 140 patients aged 18 years and older.

Is BHV-1530 the same as any other drug?

BHV-1530 is a unique investigational compound developed by Biohaven Ltd. There are no alternative names provided for this drug. It is being studied specifically for its potential role in treating solid tumors and is not known to be identical to any other approved or investigational medication.