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

NCT06874335 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BHV1530-101
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Solid Tumor

Keywords

FGFR3-targeting ADC; antibody-drug conjugate; FGRF3; ADC; FGFR3 alteration; advanced cancers

Outcome Measures

Primary Outcomes (2)

• Dose-escalation and Dose-expansion Cohorts: Number of patients with AEs

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

  Through study completion, estimated as an average of 48 months

• Dose-confirmation Cohorts: Recommended dose of BHV-1530 for later phase trials

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

  Through study completion, estimated as an average of 48 months

Secondary Outcomes (25)

• 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

• Dose-escalation and Dose-expansion Cohorts: Time to Response (TTR)

  Through study completion, estimated as an average of 48 months

• Dose-escalation and Dose-expansion Cohorts: Duration of Response (DOR)

  Through study completion, estimated as an average of 48 months

Study Arms (1)

BHV-1530 Monotherapy

EXPERIMENTAL

Drug: BHV-1530

Interventions

BHV-1530 DRUG

BHV-1530 will be administered as an IV infusion on Day 1 of each 21-day cycle

Also known as: AMB302

BHV-1530 Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed, written Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent
• Age greater than or equal to 18 years
• 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.
• Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy.
• 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.
• 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, as determined by a validated assay performed in a CLIA certified local or central laboratory.
• Measurable advanced or metastatic tumors per RECIST 1.1 criteria
• Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Acceptable liver function:
• Bilirubin ≤ 1.5 × upper limit of normal (ULN). Participants with known Gilbert's syndrome who have total bilirubin level ≤3×ULN may be enrolled.

You may not qualify if:

• 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
• Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg) or diabetes (hemoglobin A1C ≥9.0%)
• Left ventricular ejection fraction (LVEF) \<45% determined by echocardiogram or multiple gated acquisition scan (MUGA)
• Symptomatic pleural effusion (\<90% oxygen saturation)
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Primary central nervous system (CNS) tumors, current or previously treated leptomeningeal disease or known active brain metastases.
• NOTE: Participants with previously treated, clinically stable, radiologically stable brain metastases maybe eligible

Sponsors & Collaborators

• Biohaven Therapeutics Ltd.: lead

Study Sites (12)

Site-107

Denver, Colorado, 80218, United States

RECRUITING

Site-108

Lake Mary, Florida, 32746, United States

RECRUITING

Site-110

Detroit, Michigan, 48201, United States

RECRUITING

Site-115

Durham, North Carolina, 27710, United States

RECRUITING

Site-112

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Site-116

Nashville, Tennessee, 37203, United States

RECRUITING

Site-103

Austin, Texas, 78758, United States

RECRUITING

Site-104

Houston, Texas, 77030, United States

RECRUITING

Site-101

Irving, Texas, 75039, United States

RECRUITING

Site-105

San Antonio, Texas, 78229, United States

RECRUITING

Site-106

West Valley City, Utah, 84119, United States

RECRUITING

Site-102

Fairfax, Virginia, 22031, United States

RECRUITING

Central Study Contacts

Chief Medical Officer

CONTACT

203-404-0410; clinicaltrials@biohavenpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 13, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (12)