Actively Recruiting
A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors
Led by Biohaven Therapeutics Ltd. · Updated on 2026-03-11
500
Participants Needed
17
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2, first in human (FIH), open-label, multicenter study of BHV-1510 monotherapy and in Combination with Cemiplimab in participants with previously treated, advanced solid tumors.
CONDITIONS
Official Title
A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Unresectable, incurable, locally advanced or metastatic epithelial-origin solid tumor refractory to standard therapies or with no approved therapies at current treatment stage
- If applicable, received platinum-based chemotherapy, standard immunotherapy, and targeted therapies
- Measurable disease per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Adequate hematologic, renal, liver, and coagulation function as defined by lab thresholds
- Recovery to Grade 1 or better from acute toxicities of prior therapy except alopecia and vitiligo
- For combination with cemiplimab: documented advanced or metastatic cancer including proficient mismatch repair endometrial carcinoma
- Received 2 or fewer prior systemic anti-cancer therapies and at most one prior anti-PD-1/PD-L1 therapy for advanced/metastatic disease
You will not qualify if you...
- Women who are pregnant or lactating
- Clinically significant intercurrent disease
- Symptomatic brain metastases or recent brain radiation/surgery within 4 weeks prior to first dose
- Significant corneal disease
- Requires supplemental oxygen daily
- Previous treatment with Trop-2-targeted therapies including Trop-2 ADCs
- History or current interstitial lung disease or suspected based on screening imaging
- Recent cancer therapy or major surgery within specified timeframes prior to first dose
- History of severe hypersensitivity to monoclonal antibodies or BHV-1510 components
- Current or prior leptomeningeal carcinomatosis
- Use of OAP1B1 and OATP1B3 inhibitors within 14 days before starting trial
- For combination: hypersensitivity to cemiplimab or contraindications per labeling
- Prior Grade 3 or higher immune-related adverse events from PD-1/PD-L1 or similar therapies
- Prior allogeneic stem cell or solid organ transplant
- History of myocarditis
- Presence of cardiovascular disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Site-113
Duarte, California, United States, 91010
Actively Recruiting
2
Site-112
La Jolla, California, United States, 92093
Actively Recruiting
3
Site-111
Palo Alto, California, United States, 94304
Actively Recruiting
4
Site-114
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
5
Site-103
Miami, Florida, United States, 33176
Actively Recruiting
6
Site-105
Orlando, Florida, United States, 32827
Actively Recruiting
7
Site-115
Tampa, Florida, United States, 33612
Actively Recruiting
8
Site-110
Augusta, Georgia, United States, 30912
Actively Recruiting
9
Site-109
Detroit, Michigan, United States, 48201
Actively Recruiting
10
Site-101
St Louis, Missouri, United States, 63108
Actively Recruiting
11
Site-117
New York, New York, United States, 10021
Actively Recruiting
12
Site-116
Oklahoma City, Oklahoma, United States, 73117
Actively Recruiting
13
Site-108
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
14
Site-107
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
Site-104
Dallas, Texas, United States, 75231
Actively Recruiting
16
Site-106
West Valley City, Utah, United States, 84119
Actively Recruiting
17
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
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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