A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors
NCT ID: NCT06384807
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
500 participants
INTERVENTIONAL
2024-04-22
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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BHV-1510 Monotherapy Dose Escalation
BHV-1510
BHV-1510 will be administered on Day 1 every 3 weeks
BHV-1510
BHV-1510 will be administered on Day 1 every 2 weeks
BHV-1510
BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks
BHV-1510 in combination with Cemiplimab dose escalation
BHV-1510
BHV-1510 will be administered on Day 1 every 3 weeks
Cemiplimab
cemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks
BHV-1510
BHV-1510 will be administered on Day 1 every 2 weeks
BHV-1510
BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks
Cemiplimab
cemiplimab (350mg) will be administered as an IV infusion on Day 1 and Day 8 every 3 weeks
Interventions
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BHV-1510
BHV-1510 will be administered on Day 1 every 3 weeks
Cemiplimab
cemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks
BHV-1510
BHV-1510 will be administered on Day 1 every 2 weeks
BHV-1510
BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks
Cemiplimab
cemiplimab (350mg) will be administered as an IV infusion on Day 1 and Day 8 every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable, incurable, locally advanced or metastatic epithelial-origin solid tumor that is refractory to standard therapies, or has no approved standard therapies, or no approved standard therapies at its current treatment stage. If applicable to the tumor type, participants must have received platinum-based chemotherapy, standard of care immunotherapy, and standard of care targeted therapies.
* Measurable disease (per RECIST 1.1).
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
* Participants have adequate hematologic, renal, liver, and coagulation function as defined by the following (blood transfusion or growth factor support is not allowed within 7 days prior to blood samples that will be used to establish eligibility):
* Hemoglobin ≥9 g/dL
* Absolute neutrophil count \>1,500/mm3; participants with known Duffy null phenotype who have absolute neutrophil count ≥1,200/mm3 may be enrolled
* Platelets \>100,000/mm3
* Creatinine clearance ≥50 mL/min measured or estimated using the Cockcroft-Gault formula; 24-hour urine collection is allowed, but not required.
* Total bilirubin ≤1.5 × upper limit of normal (ULN); participants with known Gilbert's syndrome who have total bilirubin level ≤3×ULN may be enrolled.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5×ULN (or ≤5×ULN for participants with hepatic metastases)
* Alkaline phosphatase \<2.5×ULN (or ≤5×ULN for participants with hepatic and/or bone metastases)
* International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN
* Activated partial thromboplastin time (aPTT) ≤1.5×ULN. Study participants on therapeutic doses of anticoagulation medication must have INR and/or aPTT ≤ the upper limit of the therapeutic range for intended use
* Have recovered (ie, improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo.
* histologically or cytologically documented advanced (locally, recurrent, inoperable, cannot be treated with curative intent) or metastatic cancer.
* received ≤ 2 prior lines of systemic anti-cancer therapy and at most one prior anti-programmed cell death protein 1 (PD-1) (programmed death-ligand 1 \[PD-L1\]) therapy for advanced/ metastatic disease.
Exclusion Criteria
* Clinically significant intercurrent disease.
* Has symptomatic brain metastases or has had any radiation or surgery for brain metastases within 4 weeks of C1D1.
* Has clinically significant corneal disease.
* Requires supplemental oxygen for daily activities.
* Previous treatment with a Trop-2-targeted therapy, including Trop-2 ADCs.
* Has a medical history of interstitial lung disease (eg, noninfectious interstitial pneumonia requiring steroid treatment, pneumonitis, pulmonary fibrosis, or severe radiation pneumonitis) or current interstitial lung disease or are suspected to have any of these diseases based on imaging at Screening.
* Any standard cancer therapy (eg, chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biologic therapy treatment) or experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, prior to C1D1. The interval may be reduced to 2 weeks for bone and visceral metastasis therapy. Any major surgical procedure within 6 weeks prior to C1D1.
* History of severe hypersensitivity reactions to other monoclonal antibodies or either the drug substances or inactive ingredients of BHV-1510.
* Has current or previously treated leptomeningeal carcinomatosis.
* Use of OAP1B1 and OATP1B3 inhibitors within 14 days prior to starting trial.
* Hypersensitivity to cemiplimab or any of its excipients or contraindicated to cemiplimab per approved local labeling.
* Experienced Grade 3 or higher immune-related AEs with prior treatment of anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
* Prior allogeneic stem cell or solid organ transplantation.
* Patients with history of myocarditis.
* Presence of cardiovascular disease
18 Years
ALL
No
Sponsors
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Biohaven Therapeutics Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Biohaven Pharmaceuticals, Inc.
Locations
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Site-113
Duarte, California, United States
Site-112
La Jolla, California, United States
Site-111
Palo Alto, California, United States
Site-114
Washington D.C., District of Columbia, United States
Site-103
Miami, Florida, United States
Site-105
Orlando, Florida, United States
Site-115
Tampa, Florida, United States
Site-110
Augusta, Georgia, United States
Site-109
Detroit, Michigan, United States
Site-101
St Louis, Missouri, United States
Site-117
New York, New York, United States
Site-116
Oklahoma City, Oklahoma, United States
Site-108
Philadelphia, Pennsylvania, United States
Site-107
Nashville, Tennessee, United States
Site-104
Dallas, Texas, United States
Site-106
West Valley City, Utah, United States
Site-102
Fairfax, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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BHV1510-101 (PBI-410-101)
Identifier Type: -
Identifier Source: org_study_id
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