Solid TumorPhase 1/2NCT06384807
A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors
A Phase 1/2 study testing BHV-1510 and Cemiplimab in people with Solid Tumor, run by Biohaven Therapeutics Ltd. at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- BHV-1510 and Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 17 sitesUnited States
- Study dates
- 22 Apr 2024to Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 16 recruiting
- Recruiting
Site-110
Augusta, Georgia, 30912
- Recruiting
Site-104
Dallas, Texas, 75231
- Recruiting
Site-109
Detroit, Michigan, 48201
- Recruiting
Site-113
Duarte, California, 91010
- Recruiting
Site-102
Fairfax, Virginia, 22031
- Recruiting
Site-112
La Jolla, California, 92093
- Recruiting
Site-103
Miami, Florida, 33176
- Recruiting
Site-107
Nashville, Tennessee, 37203
- Recruiting
Site-117
New York, New York, 10021
- Recruiting
Site-116
Oklahoma City, Oklahoma, 73117
- Recruiting
Site-105
Orlando, Florida, 32827
- Recruiting
Site-111
Palo Alto, California, 94304
- Recruiting
Site-108
Philadelphia, Pennsylvania, 19107
- Completed
Site-101
St Louis, Missouri, 63108
- Recruiting
Site-115
Tampa, Florida, 33612
- Recruiting
Site-114
Washington D.C., District of Columbia, 20016
- Recruiting
Site-106
West Valley City, Utah, 84119
About this study
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
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.
Read the detailed description
This is a Phase 1/2, first in human (FIH), open-label, multicenter study of BHV-1510, a Trop-2 directed antibody-drug conjugate (ADC), in participants with previously treated, advanced solid tumors. The study comprises 2 parts: a Phase 1 Dose Escalation and a Phase 2 Dose Expansion. The Phase 1 will investigate the safety and tolerability of BHV-1510 given in monotherapy and given in combination with cemiplimab and identify one or more recommended doses for expansion (RDEs) and the maximum-tolerated dose (MTD) (if one exists). Once the RDE has been established, Phase 2 will open to investigate the preliminary efficacy of BHV-1510 in signal-finding expansion cohorts.
- Conditions
- Solid Tumor
- Being tested
- BHV-1510, Cemiplimab
- Keywords
- Trop2 targeting ADC, Antibody-drug conjugate, Trop2, ADC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-1510Drug
Also called PBI-410, GQ1010
BHV-1510 will be administered on Day 1 every 3 weeks
CemiplimabDrug
cemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks
BHV-1510Drug
Also called PBI-410, GQ1010
BHV-1510 will be administered on Day 1 every 2 weeks
BHV-1510Drug
Also called PBI-410, GQ1010
BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks
CemiplimabDrug
cemiplimab (350mg) will be administered as an IV infusion on Day 1 and Day 8 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| BHV-1510 Monotherapy Dose Escalation | Experimental | Not described Receives: Drug: BHV-1510 |
| BHV-1510 in combination with Cemiplimab dose escalation | Experimental | Not described Receives: Drug: BHV-1510; Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of patients with adverse events (AEs)
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.
Measured: Through study completion, estimated as an average of 47 months
Phase 1: Recommended doses or schedules for expansion (RDEs) and maximum tolerated dose (MTD)
Based on tolerability and preliminary antitumor activity. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.
Measured: Approximately 15 months
Phase 2: Objective Response Rate (ORR) for BHV-1510 for monotherapy and in combination with cemiplimab
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
Measured: 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
Incidence and severity of AEs, SAEs and DLTs. Severity of AEs will be assessed according to the NCI CTCAE v5.0
Measured: 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
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 47 months
Secondary outcomes (16)
Phase 1 and 2: Maximum Plasma Concentration (Cmax) of BHV-1510, total antibody and payload (BHC-0080269)
Measured: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Area Under the Concentration versus time Curve from the end of infusion to the last measurable concentration (AUClast) of BHV-1510, total antibody and payload
Measured: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Area Under the Concentration versus time curve extrapolated to infinity (AUCinf) of BHV-1510, total antibody and payload
Measured: Up to 8 timepoints, but not exceeding, 22 days in Cycle 1
Phase 1 and 2: Area under the concentration versus time curve over the dosing interval (AUCtau) of BHV-1510, total antibody and payload
Measured: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Elimination half-life (t1/2) of BHV-1510, total antibody and payload
Measured: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Trough concentration (Ctrough) of BHV-1510, total antibody and payload
Measured: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Total body clearance (CL) after IV administration or apparent total body clearance (CL/F) after SC administration of BHV-1510 and total antibody
Measured: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Percent bioavailability (%F) after SC administration of BHV-1510 and total antibody
Measured: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Volume of distribution at steady state (Vss) after IV administration or apparent volume of distribution at steady state (Vss/F) after SC administration of BHV-1510 and total antibody
Measured: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1: ORR
Assessed by RECIST v 1.1. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.
Measured: Through study completion, estimated as an average of 47 months
Phase 1: Duration of Response (DoR)
Assessed by RECIST v 1.1. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.
Measured: Through study completion, estimated as an average of 47 months
Phase 1 and 2: Immunogenicity of BHV-1510
Incidence of ADA at baseline and post-treatment, including ADA titer
Measured: Through study completion, estimated as an average of 47 months
Phase 2: Disease control rate (DCR) for BHV-1510 for monotherapy and in combination with cemiplimab
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 47 months
Phase 2: Progression free survival (PFS) for BHV-1510 for monotherapy and in combination with cemiplimab
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 47 months
Phase 2: Overall survival (OS) for BHV-1510 for monotherapy and in combination with cemiplimab
OS is defined as the time period from the start of administration to death due to any cause
Measured: Through study completion, estimated as an average of 47 months
Phase 2: Effects of BHV-1510 monotherapy and payload on the QTc interval using the Fridericia's correction method (QTcF), and on other ECG parameters (heart rate [HR], PR, and QRS interval)
Measured: Approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start22 Apr 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Biohaven Therapeutics Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation followed by enrollment in signal-finding cohorts.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Biohaven Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384807
- Sponsor's protocol ID
- BHV1510-101 (PBI-410-101)
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06384807
- Acronym / sponsor ID
- BHV1510-101 (PBI-410-101)
- Conditions
- Solid Tumor
- Keywords
- Trop2 targeting ADC, Antibody-drug conjugate, Trop2, ADC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1/2, first in human (FIH), open-label, multicenter study of BHV-1510, a Trop-2 directed antibody-drug conjugate (ADC), in participants with previously treated, advanced solid tumors. The study comprises 2 parts: a Phase 1 Dose Escalation and a Phase 2 Dose Expansion. The Phase 1 will investigate the safety and tolerability of BHV-1510 given in monotherapy and given in combination with cemiplimab and identify one or more recommended doses for expansion (RDEs) and the maximum-tolerated dose (MTD) (if one exists). Once the RDE has been established, Phase 2 will open to investigate the preliminary efficacy of BHV-1510 in signal-finding expansion cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose escalation followed by enrollment in signal-finding cohorts.
| Arm | Type | Receives |
|---|---|---|
| BHV-1510 Monotherapy Dose Escalation | Experimental | Drug: BHV-1510 |
| BHV-1510 in combination with Cemiplimab dose escalation | Experimental | Drug: BHV-1510, Drug: Cemiplimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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):
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHV-1510Also: PBI-410, GQ1010BHV-1510 will be administered on Day 1 every 3 weeks | Drug | BHV-1510 Monotherapy Dose Escalation, BHV-1510 in combination with Cemiplimab dose escalation |
| Cemiplimabcemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks | Drug | BHV-1510 in combination with Cemiplimab dose escalation |
| BHV-1510Also: PBI-410, GQ1010BHV-1510 will be administered on Day 1 every 2 weeks | Drug | BHV-1510 Monotherapy Dose Escalation, BHV-1510 in combination with Cemiplimab dose escalation |
| BHV-1510Also: PBI-410, GQ1010BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks | Drug | BHV-1510 Monotherapy Dose Escalation, BHV-1510 in combination with Cemiplimab dose escalation |
| Cemiplimabcemiplimab (350mg) will be administered as an IV infusion on Day 1 and Day 8 every 3 weeks | Drug | BHV-1510 in combination with Cemiplimab dose escalation |
Primary outcome
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
16 secondary outcomes
Phase 1 and 2: Maximum Plasma Concentration (Cmax) of BHV-1510, total antibody and payload (BHC-0080269)
Time frame: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Area Under the Concentration versus time Curve from the end of infusion to the last measurable concentration (AUClast) of BHV-1510, total antibody and payload
Time frame: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Area Under the Concentration versus time curve extrapolated to infinity (AUCinf) of BHV-1510, total antibody and payload
Time frame: Up to 8 timepoints, but not exceeding, 22 days in Cycle 1
Phase 1 and 2: Area under the concentration versus time curve over the dosing interval (AUCtau) of BHV-1510, total antibody and payload
Time frame: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Elimination half-life (t1/2) of BHV-1510, total antibody and payload
Time frame: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Trough concentration (Ctrough) of BHV-1510, total antibody and payload
Time frame: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Total body clearance (CL) after IV administration or apparent total body clearance (CL/F) after SC administration of BHV-1510 and total antibody
Time frame: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Percent bioavailability (%F) after SC administration of BHV-1510 and total antibody
Time frame: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1 and 2: Volume of distribution at steady state (Vss) after IV administration or apparent volume of distribution at steady state (Vss/F) after SC administration of BHV-1510 and total antibody
Time frame: Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
Phase 1: ORR
Time frame: Through study completion, estimated as an average of 47 months
Phase 1: Duration of Response (DoR)
Time frame: Through study completion, estimated as an average of 47 months
Phase 1 and 2: Immunogenicity of BHV-1510
Time frame: Through study completion, estimated as an average of 47 months
Phase 2: Disease control rate (DCR) for BHV-1510 for monotherapy and in combination with cemiplimab
Time frame: Through study completion, estimated as an average of 47 months
Phase 2: Progression free survival (PFS) for BHV-1510 for monotherapy and in combination with cemiplimab
Time frame: Through study completion, estimated as an average of 47 months
Phase 2: Overall survival (OS) for BHV-1510 for monotherapy and in combination with cemiplimab
Time frame: Through study completion, estimated as an average of 47 months
Phase 2: Effects of BHV-1510 monotherapy and payload on the QTc interval using the Fridericia's correction method (QTcF), and on other ECG parameters (heart rate [HR], PR, and QRS interval)
Time frame: Approximately 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chief Medical Officer study director
Biohaven Pharmaceuticals, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BHV-1510 and Cemiplimab in people with Solid Tumor, run by Biohaven Therapeutics Ltd. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Medical Officer (203-404-0410, clinicaltrials@biohavenpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Number of patients with adverse events (AEs) (time frame: Through study completion, estimated as an average of 47 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.