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Testing BHV-1510 for advanced solid tumors

A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of BHV-1510 (Previously PBI-410) as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors

Phase1; Phase2 Interventional Biohaven Pharmaceuticals, Inc. · NCT06384807

This study is testing a new treatment called BHV-1510 for people with advanced solid tumors that have already been treated, to see how safe it is and if it works better alone or with another drug.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorBiohaven Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionscemiplimab, chemotherapy, immunotherapy, radiation
Locations17 sites (Duarte, California and 16 other locations)
Trial IDNCT06384807 on ClinicalTrials.gov

What this trial studies

This is a Phase 1/2, first in human, open-label, multicenter study evaluating BHV-1510, a Trop-2 directed antibody-drug conjugate, in patients with previously treated advanced solid tumors. The study consists of two parts: a Phase 1 dose escalation to assess safety and tolerability, and a Phase 2 dose expansion to evaluate preliminary efficacy. Participants will receive BHV-1510 alone or in combination with cemiplimab, with the aim of identifying recommended doses and maximum-tolerated doses for further investigation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable, incurable, locally advanced or metastatic epithelial-origin solid tumors that are refractory to standard treatments.

Not a fit: Patients with solid tumors that have not been previously treated or those with tumors for which there are effective standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have not responded to standard therapies.

How similar studies have performed: Other studies involving antibody-drug conjugates have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

BHV-1510 in Combination with specific inclusion criteria:

* 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.

Key Exclusion Criteria:

* 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.

BHV-1510 in Combination Specific Exclusion Criteria:

* 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

Where this trial is running

Duarte, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorTrop2 targeting ADCAntibody-drug conjugateTrop2ADC
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.