NCT06384807 · Biohaven Therapeutics Ltd.
A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors
What this study is about
This is a Phase 1/2, first in human (FIH), where both patients and doctors know the treatment given, conducted at multiple hospitals study of BHV-1510 treatment given alone and in Combination with Cemiplimab in participants with previously treated, advanced solid tumors.
View original scientific 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.
Interventions
DRUG
BHV-1510
BHV-1510 will be administered on Day 1 every 3 weeks
DRUG
Cemiplimab
cemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks
DRUG
BHV-1510
BHV-1510 will be administered on Day 1 every 2 weeks
DRUG
BHV-1510
BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks
DRUG
Cemiplimab
cemiplimab (350mg) will be administered as an IV infusion on Day 1 and Day 8 every 3 weeks
Primary outcome measures
Phase 1: Number of patients with adverse events (AEs)
Time frame: 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)
Time frame: 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 cemiplimab
Time frame: Through 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 cemiplimab
Time frame: Through 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 cemiplimab
Time frame: Through study completion, estimated as an average of 47 months
Assessed by RECIST v 1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 en
Where
- Duarte, California
- La Jolla, California
- Palo Alto, California
- Washington D.C., District of Columbia
- Miami, Florida
- Orlando, Florida
- Tampa, Florida
- Augusta, Georgia
- Detroit, Michigan
- St Louis, Missouri
- New York, New York
- Oklahoma City, Oklahoma
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations