Actively Recruiting
A Phase 1 Study of BHV-1530 in Advanced Solid Tumors
Led by Biohaven Therapeutics Ltd. · Updated on 2026-05-13
95
Participants Needed
13
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Willing to provide tumor tissue collected within 90 days prior to treatment
- Have progressed following or are intolerant to standard therapies or have no available standard treatment
- Have histologically or cytologically confirmed locally advanced or metastatic solid tumors including urothelial cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, or other solid tumors with FGFR3 alterations
- Measurable tumors per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Acceptable liver function (bilirubin ≤1.5× ULN, AST/ALT/alkaline phosphatase ≤2.5× ULN or ≤5× ULN if liver metastases present)
- Acceptable kidney function (serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min)
- Acceptable blood counts (neutrophils ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥9 g/dL)
- Negative pregnancy test if woman of childbearing potential
- Agreement to use effective contraception during and after the study (7 months for women, 4 months for men)
You will not qualify if you...
- Prior treatment with antibody drug conjugates containing topoisomerase-I inhibitors
- Significant heart disease including recent heart attack or unstable angina within 6 months, severe heart failure, uncontrolled arrhythmia, or severe aortic stenosis
- Active infections requiring systemic therapy
- Primary CNS tumors, untreated or active brain metastases (treated stable brain metastases may be allowed)
- Pregnant or nursing women
- Recent cancer therapy or major surgery within specified time frames before study start
- Unrecovered toxicities from prior treatments except alopecia and vitiligo
- Significant eye abnormalities increasing risk of toxicity
- Active infections with HIV, HTLV-1, hepatitis B or C unless controlled per protocol
- Active second malignancy unless fully treated and low risk of recurrence
- Inability to comply with study procedures or treatment
- Sensitivity to BHV-1530 or its components
- History or active interstitial lung disease requiring steroids
- Need for supplemental oxygen for daily activities
- Recent live vaccine within 4 weeks before starting study drug
AI-Screening
AI-Powered Screening
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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
CONTACT
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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