RECRUITING

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

Conditions

Solid Tumor Trop2 targeting ADC Antibody-drug conjugate Trop2 ADC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-22

Study Completion:2028-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06384807

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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.	* 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-only radiation 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. * 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 most recent imaging.

Inclusion Criteria

Exclusion 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
* 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.

* 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-only radiation 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.
* 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 most recent imaging.

Contacts and Locations

Study Contact

Chief Medical Officer

CONTACT

203-404-0410

clinicaltrials@biohavenpharma.com

Principal Investigator

Chief Medical Officer

STUDY_DIRECTOR

Biohaven Pharmaceuticals, Inc.

Study Locations (Sites)

Miami Baptist

Miami, Florida, 33176

United States

SCRI Lake Nona: Florida Cancer Specialists

Orlando, Florida, 32827

United States

NEXT Dallas

Dallas, Texas, 75231

United States

START Mountain Region

West Valley City, Utah, 84119

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Biohaven Therapeutics Ltd.

Chief Medical Officer, STUDY_DIRECTOR, Biohaven Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-22

Study Completion Date2028-02

Study Record Updates

Study Start Date2024-04-22

Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

Trop2 targeting ADC
Antibody-drug conjugate
Trop2
ADC

Additional Relevant MeSH Terms

Solid Tumor