Recruiting
Phase 1
Phase 2

BHV-1510 & Cemiplimab

Sponsor:

Biohaven Therapeutics Ltd.

Code:

NCT06384807

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BHV-1510

Cemiplimab

BHV-1510

BHV-1510

Cemiplimab

Study Details

Brief summary:

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

Solid Tumor

Study ID

NCT06384807

Start date

Apr 22, 2024

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BHV-1510 Monotherapy Dose Escalation

experimental: BHV-1510 in combination with Cemiplimab dose escalation

Interventions

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

Primary outcome measure

  • Phase 1: Number of patients with adverse events (AEs) [ Time Frame: Through study completion, estimated as an average of 47 months ]
  • Phase 1: Recommended doses or schedules for expansion (RDEs) and maximum tolerated dose (MTD) [ Time Frame: Approximately 15 months ]
  • Phase 2: Objective Response Rate (ORR) for BHV-1510 for monotherapy and in combination with cemiplimab [ Time Frame: Through study completion, estimated as an average of 47 months ]
  • Phase 2: Number of patients with AEs for BHV-1510 for monotherapy and in combination with cemiplimab [ Time Frame: Through study completion, estimated as an average of 47 months ]
  • Phase 2: Duration of Response (DoR) for BHV-1510 for monotherapy and in combination with cemiplimab [ Time Frame: Through study completion, estimated as an average of 47 months ]

Central Contacts and Locations

Central contacts

Chief Medical Officer

203-404-0410clinicaltrials@biohavenpharma.com

Locations

Site-113

Recruiting

Duarte, California, United States, 91010

Site-112

Recruiting

La Jolla, California, United States, 92093

Site-111

Recruiting

Palo Alto, California, United States, 94304

Site-114

Recruiting

Washington D.C., District of Columbia, United States, 20016

Site-103

Recruiting

Miami, Florida, United States, 33176

Site-105

Recruiting

Orlando, Florida, United States, 32827

Site-115

Recruiting

Tampa, Florida, United States, 33612

Site-110

Recruiting

Augusta, Georgia, United States, 30912

Site-109

Recruiting

Detroit, Michigan, United States, 48201

Site-101

Recruiting

St Louis, Missouri, United States, 63108

Site-117

Recruiting

New York, New York, United States, 10021

Site-116

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Site-108

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Site-107

Recruiting

Nashville, Tennessee, United States, 37203

Site-104

Recruiting

Dallas, Texas, United States, 75231

Site-106

Recruiting

West Valley City, Utah, United States, 84119

Site-102

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Biohaven Therapeutics Ltd.

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Trop2 targeting ADC
  • Antibody-drug conjugate
  • Trop2
  • ADC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Biohaven Therapeutics Ltd. on 2026-03-11.