Actively Recruiting
A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of BHV-1510 as Monotherapy and Combined with Cemiplimab in Participants with Advanced Solid Tumors
Led by Biohaven Therapeutics Ltd. · Updated on 2026-03-11
500
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BHV-1510, a Trop-2 directed antibody-drug conjugate, alone and combined with cemiplimab in adults with previously treated, advanced solid tumors that are incurable or have no standard therapies left. This Phase 1/2 open-label study aims to assess safety, tolerability, and preliminary effectiveness in this population, including determination of recommended doses and maximum tolerated doses of BHV-1510. The study includes two parts: Phase 1 dose escalation to test BHV-1510 alone and with cemiplimab, and Phase 2 dose expansion to further assess response rates and safety. BHV-1510 is given intravenously on various schedules, including every 2 or 3 weeks, sometimes with cemiplimab infusions every 3 weeks. The combination dosing regimens vary, with cemiplimab given at 350 mg on Day 1 or Day 1 and Day 8 every 3 weeks. Participants will undergo regular safety assessments, including monitoring adverse events and laboratory tests. Researchers will measure BHV-1510 levels in blood and evaluate tumor response using imaging and standard criteria. The study may last up to about 47 months, with ongoing follow-up to assess duration of response, progression-free survival, overall survival, and other clinical outcomes. Safety and tolerability will be closely monitored throughout the study.
CONDITIONS
Brief 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 without approved standard therapies
- Received platinum-based chemotherapy, standard immunotherapy, and targeted therapies if applicable to tumor type
- Measurable disease per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate hematologic, renal, liver, and coagulation function with specified lab values
- Recovery from acute toxicities of prior therapy except alopecia and vitiligo
- For combination with cemiplimab: 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 before starting trial
- Clinically significant corneal disease
- Requires supplemental oxygen for daily activities
- Previous treatment with Trop-2-targeted therapies including Trop-2 ADCs
- History or current interstitial lung disease or suspicion based on imaging
- Recent standard or experimental cancer therapy within 3 weeks or 5 half-lives (shorter interval for metastasis therapy)
- Major surgery within 6 weeks prior to study start
- History of severe hypersensitivity to monoclonal antibodies or BHV-1510 components
- Current or treated leptomeningeal carcinomatosis
- Use of OAP1B1 and OATP1B3 inhibitors within 14 days prior to trial
- For combination with cemiplimab: hypersensitivity to cemiplimab, prior severe immune-related adverse events, prior allogeneic transplant, history of myocarditis, or cardiovascular disease
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-1510 as monotherapy or in combination with cemiplimab according to assigned dose escalation or expansion schedules.
Treatment visits every 1 or 2 weeks depending on dosing schedule
Duration - Up to approximately 47 months
Participants are monitored for safety, efficacy, and long-term outcomes after treatment ends.
Periodic visits as scheduled for assessments
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
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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