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RECRUITINGPHASE1

A Phase 1 Study of BHV-1530 in Advanced Solid Tumors

A Phase 1, Multicenter, Open-Label, Dose Escalation, Dose Expansion and Dose Confirmation Study of BHV-1530 in Adult Patients With Advanced or Metastatic Solid Tumors

NCT06874335•Biohaven Therapeutics Ltd.

View on ClinicalTrials.gov

Summary

This is a Phase 1, first in human (FIH), open-label, multicenter study of BHV-1530 in adult participants with advanced or metastatic solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 their last anticancer therapy and within 90 days of the start of study treatment. An older archival sample may be acceptable with Sponsor approval.
•4. Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy.
•5. Patients with histologically or cytologically confirmed locally advanced/metastatic relapsed or refractory solid tumors as outlined below:
•* Dose-escalation and Dose-expansion (Backfill) Cohorts:
•* Participants with urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) regardless of the presence of an activating FGFR3 alteration (mutation, fusion, or amplification) or high FGFR3 protein or mRNA expression in the absence of a detectable genetic alteration.
•* Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation, fusion, or amplification) or high FGFR3 protein or mRNA expression in the absence of a detectable genetic alteration.
•* Dose Confirmation Cohort:
•* Participants with urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) regardless of the presence of an activating FGFR3 alteration (mutation, fusion, or amplification) or high FGFR3 protein or mRNA expression in the absence of a detectable genetic alteration.
+16 more criteria

Exclusion Criteria

•1. Prior treatment with antibody drug conjugate (ADC) with a topoisomerase-I inhibitor payload. Prior direct treatment with topoisomerase inhibitor (e.g., irinotecan, topotecan, belotecan, nano-liposomal irinotecan) are not exclusionary.
•2. Participant has clinically significant intercurrent disease including, but not limited to:
•* New York Heart Association Class III or IV heart failure
•* Myocardial infarction, unstable angina, or stroke ≤ 6 months prior to C1D1
•* Newly diagnosed thromboembolic events that require therapeutic intervention over the last 6 months prior to C1D1 (participants with stable control of lower limb deep venous thrombosis over at least 3 months are allowed)
•* Severe aortic stenosis
•* Uncontrolled arrhythmia
•* Symptomatic pericardial effusion
•* Congenital long QT syndrome
•* A mean of Fredericia's formula-QT corrected interval (QTcF) prolongation to \>470 msec based on a 12-lead ECG
+17 more criteria

Locations (12)

Site-107

Denver, Colorado, United States

Site-108

Lake Mary, Florida, United States

Site-110

Detroit, Michigan, United States

Site-115

Durham, North Carolina, United States

Site-112

Myrtle Beach, South Carolina, United States

Site-116

Nashville, Tennessee, United States

Site-103

Austin, Texas, United States

Site-104

Houston, Texas, United States

Site-101

Irving, Texas, United States

Site-105

San Antonio, Texas, United States

Key Dates

Start Date

March 20, 2025

Primary Completion Date

March 1, 2029

Completion Date

March 1, 2029

Last Updated

November 18, 2025

Enrollment

ESTIMATED participants

Conditions

Solid Tumor

Interventions

BHV-1530

DRUG

Contacts

Chief Medical Officer

CONTACT

203-404-0410 clinicaltrials@biohavenpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1 Study of BHV-1530 in Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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