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New treatment option for Solid Tumor
Official title A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06384807
What this study is testing
What is BHV-1510?
BHV-1510 is an investigational medicine, being studied as a potential treatment for solid tumor.
Also referred to as PBI-410, GQ1010.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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
- 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...
- 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
- 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...
- 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...
- 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...
- Prior allogeneic stem cell or solid organ transplantation.
- Patients with history of myocarditis.
- Presence of cardiovascular disease
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- La Jolla, California, United States
- Palo Alto, California, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Augusta, Georgia, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; La Jolla, California, United States; Palo Alto, California, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Orlando, Florida, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.