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: 140
• Locations: 1 country
• Sites: 17

Brief Summary

This is a Phase 1, first in human (FIH), Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination with Other Anti-Cancer Agents 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; cemiplimab

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Through study completion, estimated as an average of 48 months

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

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

  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 (2)

BHV-1530 Monotherapy

EXPERIMENTAL

Drug: BHV-1530

Experimental: BHV-1530 in combination with Cemiplimab

EXPERIMENTAL

Drug: BHV-1530; Drug: Cemiplimab

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; Experimental: BHV-1530 in combination with Cemiplimab

Cemiplimab DRUG

cemiplimab (350 mg) will be administered as an IV infusion on Day 1 of each 21-day cycle

Experimental: BHV-1530 in combination with Cemiplimab

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 (BHV-1530 monotherapy):
• 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) of the oral cavity, hypopharynx, oropharynx, nasopharynx, larynx and sinonasal tract.
• Tumors originating from the salivary glands, or unknown primary sites are not eligible.
• Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion).
• Dose Escalation and Dose Expansion (Backfill) Cohorts (BHV-1530 in combination with cemiplimab):
• 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) of the oral cavity, hypopharynx, oropharynx, nasopharynx, larynx and sinonasal tract.
• Tumors originating from the salivary glands, or unknown primary sites are not eligible.
• Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion).
• Participants must have received ≤ 2 prior lines of systemic anti-cancer therapy which may include at most one prior anti-programmed cell death protein 1 (PD-1) (programmed death-ligand 1 \[PD-L1\]) therapy for advanced/metastatic disease.
• Dose Optimization Cohorts (BHV-1530 monotherapy):

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 4 months prior to C1D1 (participants with stable control of lower limb deep venous thrombosis over at least 1 months are allowed, and participants with incidental, asymptomatic pulmonary embolism and clinically stable for at least 1 month prior to C1D1 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 triplicate 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)
• 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
• Pregnant or nursing women

Sponsors & Collaborators

• Biohaven Therapeutics Ltd.: lead

Study Sites (17)

Site-111

Newport Beach, California, 92663, United States

RECRUITING

Site-107

Denver, Colorado, 80218, United States

RECRUITING

Site-108

Lake Mary, Florida, 32746, United States

WITHDRAWN

Site-121

Miami, Florida, 33136, United States

RECRUITING

Site-118

Orlando, Florida, 32804, United States

RECRUITING

Site-120

Ann Arbor, Michigan, 48109, United States

RECRUITING

Site-110

Detroit, Michigan, 48201, United States

RECRUITING

Site-115

Durham, North Carolina, 27710, United States

RECRUITING

Site-122

Cleveland, Ohio, 44195, 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

MeSH Terms

Interventions

cemiplimab

Central Study Contacts

Chief Medical Officer

CONTACT

203-404-0410; clinicaltrials@biohavenpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• 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: July 9, 2026

Record last verified: 2026-07

Locations

US (17)