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Phase 1/2 Study of BHV-1510 for Advanced Solid Tumors

This study is testing a new drug called BHV-1510, either alone or with cemiplimab, for people with advanced solid tumors that haven't responded to other treatments. BHV-1510 is a type of targeted therapy called an antibody-drug conjugate (ADC), and cemiplimab is an immunotherapy. The first part of the study will find the safest and most effective dose of BHV-1510. The second part will then look at how well BHV-1510 works to shrink tumors. You may be able to join if you are 18 or older and have an advanced solid tumor that is not treatable with standard therapies. The study plans to enroll up to 500 participants, but its current recruitment status is unclear.

Study design
This is a Phase 1/2, open-label study, meaning you and your doctors will know which treatment you are receiving. It is a 'first-in-human' study, testing BHV-1510 for the first time in people.
What's involved
BHV-1510 will be given on Day 1 every 3 weeks, or on Day 1 every 2 weeks, or on Day 1 and Day 8 every 3 weeks. Cemiplimab will be given on Day 1 every 3 weeks, or on Day 1 and Day 8 every 3 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events (side effects) and how well the treatment works through study completion, estimated to be an average of 47 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06384807

A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Biohaven Therapeutics Ltd.
~500 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:BHV-1510Cemiplimab

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Number of patients with adverse events (AEs)
Measured over Through study completion, estimated as an average of 47 months
+4 more outcomes measured

Conditions

Solid Tumor

Explore related trials

Endometrial CarcinomaSolid Neoplasm

Where it's being run

17 sites across 13 states
California3
Florida3
District of Columbia1
Georgia1
Michigan1
Missouri1
New York1
Oklahoma1

Study leadership

  • Chief Medical Officer · STUDY_DIRECTOR · Biohaven Pharmaceuticals, Inc.

Who to contact

Chief Medical Officer
[email protected]
203-404-0410
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female participants aged ≥18 years.
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 betreated with curative intent) or metastatic cancer including Endometrial Carcinoma that is confirmed as proficient mismatch repair (pMMR)
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

Women who are pregnant or lactating.
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

What this trial measures

  • Phase 1: Number of patients with adverse events (AEs)Through study completion, estimated as an average of 47 months

    Description: Incidence and severity of AEs, serious adverse events (SAEs) and dose limiting toxicities (DLTs). Severity of AEs will be assessed according to the NCI CTCAE v5.0. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.

  • Phase 1: Recommended doses or schedules for expansion (RDEs) and maximum tolerated dose (MTD)Approximately 15 months

    Based on tolerability and preliminary antitumor activity. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.

  • Phase 2: Objective Response Rate (ORR) for BHV-1510 for monotherapy and in combination with cemiplimabThrough study completion, estimated as an average of 47 months

    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.

  • Phase 2: Number of patients with AEs for BHV-1510 for monotherapy and in combination with cemiplimabThrough study completion, estimated as an average of 47 months

    Incidence and severity of AEs, SAEs and DLTs. Severity of AEs will be assessed according to the NCI CTCAE v5.0

  • Phase 2: Duration of Response (DoR) for BHV-1510 for monotherapy and in combination with cemiplimabThrough study completion, estimated as an average of 47 months

    Assessed by RECIST v 1.1