Actively Recruiting
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
Led by Biohaven Therapeutics Ltd. · Updated on 2026-05-13
95
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BHV-1530 in adults with advanced or metastatic solid tumors in this Phase 1, first-in-human, open-label, multicenter study. The study aims to assess the safety and appropriate dosing of BHV-1530 while monitoring patients who have progressed after or are intolerant to standard therapies. It focuses on tumors such as urothelial cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma, including those with FGFR3 alterations or high FGFR3 expression. Participants receive BHV-1530 as an intravenous infusion on Day 1 of each 21-day cycle. The study includes dose-escalation, dose-expansion, and dose-confirmation phases to determine the recommended dose for later trials. Treatment continues under close observation to evaluate adverse events and clinical responses over approximately 48 months. During the study, participants undergo regular assessments including tumor measurements by RECIST 1.1 criteria, performance status evaluations, blood tests, liver and kidney function tests, and pregnancy tests if applicable. Researchers will track adverse events, clinical benefit rates, response durations, progression-free survival, and drug concentration levels in the blood. Safety monitoring and follow-up continue through the study completion period, which is estimated to average 48 months per participant.
CONDITIONS
Brief Title
A Phase 1 Study of BHV-1530 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent approved by an ethics committee
- Age 18 years or older
- Willingness to provide tumor tissue collected prior to study treatment, preferably within 90 days
- Progressed after, intolerant of, or have no standard therapy available
- Diagnosis of histologically or cytologically confirmed advanced or metastatic relapsed/refractory solid tumors as specified
- Measurable tumors per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Acceptable liver, renal, and hematologic function as defined in the protocol
- Negative pregnancy test if applicable
- Agreement to use contraception during and after study participation as specified
You will not qualify if you...
- Prior treatment with antibody drug conjugate containing topoisomerase-I inhibitor payload
- Significant heart conditions including recent myocardial infarction, heart failure class III/IV, uncontrolled arrhythmia, or severe aortic stenosis
- Active infections requiring systemic therapy
- Primary central nervous system tumors, active brain metastases, or leptomeningeal disease
- Pregnant or nursing women
- Recent cancer therapies or major surgery within defined timeframes before study start
- Unrecovered toxicities from prior treatments except alopecia or vitiligo
- Significant eye abnormalities increasing risk of toxicity
- Active infections with HIV/AIDS, hepatitis B or C under certain conditions
- Active second malignancy except certain low-risk cancers
- Inability or unwillingness to comply with study procedures
- Known sensitivity to BHV-1530 or its ingredients
- Significant interstitial lung disease or pneumonitis
- Requirement for supplemental oxygen daily
- Recent live attenuated vaccine within 4 weeks prior to treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive BHV-1530 as an intravenous infusion on Day 1 of each 21-day cycle to treat advanced or metastatic solid tumors.
1 visit per 21-day cycle (in-person)
Trial Site Locations
Total: 13 locations
1
Site-107
Denver, Colorado, United States, 80218
Actively Recruiting
2
Site-108
Lake Mary, Florida, United States, 32746
Withdrawn
3
Site-121
Miami, Florida, United States, 33136
Actively Recruiting
4
Site-110
Detroit, Michigan, United States, 48201
Actively Recruiting
5
Site-115
Durham, North Carolina, United States, 27710
Actively Recruiting
6
Site-112
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
7
Site-116
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
Site-103
Austin, Texas, United States, 78758
Actively Recruiting
9
Site-104
Houston, Texas, United States, 77030
Actively Recruiting
10
Site-101
Irving, Texas, United States, 75039
Actively Recruiting
11
Site-105
San Antonio, Texas, United States, 78229
Actively Recruiting
12
Site-106
West Valley City, Utah, United States, 84119
Actively Recruiting
13
Site-102
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
C
Chief Medical Officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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