Solid TumorPhase 1NCT06874335
A Phase 1 Study of BHV-1530 in Advanced Solid Tumors
A Phase 1 study testing BHV-1530 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, first in human (FIH), Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination with Other Anti-Cancer Agents in Adult Participants with Advanced or Metastatic 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-1530 and Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 17 sitesUnited States
- Study dates
- 20 Mar 2025to Mar 2029
- Phase
- Phase 1
- 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
- Signed, written Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent
- Age greater than or equal to 18 years
- Participants consent to provide tumor tissue collected prior to study treatment, preferably from a biopsy performed after their last anticancer therapy and within 90 days of the start of study treatment. An older archival sample may be acceptable with Sponsor approval.
- Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy.
- Patients with histologically or cytologically confirmed locally advanced/metastatic relapsed or refractory solid tumors as outlined below:
- Dose Escalation and Dose Expansion (Backfill) Cohorts (BHV-1530 monotherapy):
Show all 69Show fewer
- Participants with urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) of the oral cavity, hypopharynx, oropharynx, nasopharynx, larynx and sinonasal tract.
- Tumors originating from the salivary glands, or unknown primary sites are not eligible.
- Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion).
- Dose Escalation and Dose Expansion (Backfill) Cohorts (BHV-1530 in combination with cemiplimab):
- Participants with urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) of the oral cavity, hypopharynx, oropharynx, nasopharynx, larynx and sinonasal tract.
- Tumors originating from the salivary glands, or unknown primary sites are not eligible.
- Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion).
- Participants must have received ≤ 2 prior lines of systemic anti-cancer therapy which may include at most one prior anti-programmed cell death protein 1 (PD-1) (programmed death-ligand 1 [PD-L1]) therapy for advanced/metastatic disease.
- Dose Optimization Cohorts (BHV-1530 monotherapy):
- oParticipants with urothelial cancer of the urinary tract: (including renal pelvis, ureters, urinary bladder, and urethra)..
- Measurable advanced or metastatic tumors per RECIST 1.1 criteria
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Acceptable liver function:
- Bilirubin ≤ 1.5 × upper limit of normal (ULN). Participants with known Gilbert's syndrome who have total bilirubin level ≤3×ULN may be enrolled.
- AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN (if liver metastases are present, then ≤ 5 × ULN is allowed)
- Acceptable renal function:
- Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min as calculated using the modified Cockcroft-Gault equation; confirmation of creatinine clearance is only required when creatinine is >1.5 × ULN; 24-hour urine collection is allowed, but not required
- Acceptable hematologic status:
- Blood transfusion or growth factor support is not allowed within 7 days prior to blood samples that will be used to establish eligibility
- Absolute neutrophil count greater than or equal to 1500/mm3. Participants with known Duffy null phenotype who have absolute neutrophil count ≥ 1,200/mm3 may be enrolled
- Platelet count greater than or equal to 100,000 mm3
- Hemoglobin greater than or equal to 9 g/dL
- 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
- A negative urine or serum pregnancy test (if a woman of childbearing potential);
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 7 months (for women) or 4 months (for men) after the last dose of study drug.
- General Exclusion Criteria:
- Prior treatment with antibody drug conjugate (ADC) with a topoisomerase-I inhibitor payload. Prior direct treatment with topoisomerase inhibitor (e.g., irinotecan, topotecan, belotecan, nano-liposomal irinotecan) are not exclusionary.
- Participant has clinically significant intercurrent disease including, but not limited to:
- New York Heart Association Class III or IV heart failure
- Myocardial infarction, unstable angina, or stroke ≤ 6 months prior to C1D1
- Newly diagnosed thromboembolic events that require therapeutic intervention over the last 4 months prior to C1D1 (participants with stable control of lower limb deep venous thrombosis over at least 1 months are allowed, and participants with incidental, asymptomatic pulmonary embolism and clinically stable for at least 1 month prior to C1D1 are allowed)
- Severe aortic stenosis
- Uncontrolled arrhythmia
- Symptomatic pericardial effusion
- Congenital long QT syndrome
- A mean of Fredericia's formula-QT corrected interval (QTcF) prolongation to >470 msec based on a triplicate 12-lead ECG
- Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg) or diabetes (hemoglobin A1C ≥9.0%)
- Left ventricular ejection fraction (LVEF) <45% determined by echocardiogram or multiple gated acquisition scan (MUGA)
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Primary central nervous system (CNS) tumors, current or previously treated leptomeningeal disease or known active brain metastases.
- NOTE: Participants with previously treated, clinically stable, radiologically stable brain metastases maybe eligible
- Pregnant or nursing women
- Any standard cancer therapy (e.g., chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biologic therapy treatment) or experimental therapy within 4 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
- Participants have not recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo. If the participant has an ongoing, stable, chronic Grade 2 toxicity they may be eligible after discussion with Sponsor on a case-by-case basis
- Any clinically significant corneal or retinal abnormality that may increase the risk of eye toxicity
- Known active infection with human immunodeficiency virus (HIV), human T-cell leukemia virus, type 1 (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV), if allowed by local regulations:
- Participants with hepatitis B (hepatitis B virus surface antigen [HbsAg] positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid). Participants with HCV with undetectable virus after treatment are eligible. Participants with a prior history of hepatitis B virus are eligible if quantitative polymerase change reaction for hepatitis B virus DNA is negative
- Participants with human immunodeficiency virus (HIV) infection with acquired immune deficiency syndrome (AIDS) defining illness are not eligible for enrollment; however, participants who have had HIV infection and who have a cluster of differentiation 4 (CD4) + T cell count >350 cells/μL and no history of an AIDS-defining illness are eligible for entry
- Has an active second malignancy. Note: participants with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with tumors cured with radiotherapy or surgery with low risk of recurrence (e.g., non melanoma skin cancer, histologically confirmed complete excision of carcinoma in situ) are allowed
- Participants who in the opinion of the Investigator will not be able to adhere to the schedule of assessments and/or may have difficulties complying with the treatment regimen or are unwilling or unable to comply with procedures required in this protocol
- Known sensitivity to BHV-1530 or any of the excipients in BHV-1530;
- History of (noninfectious) clinically significant interstitial lung disease (ILD)/pneumonitis that required steroids, active clinically significant ILD/pneumonitis, or suspected clinically significant ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Requires supplemental oxygen for daily activities
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
- Combination Specific Exclusion Criteria:
- To be eligible to participate in the combination arms of the study, participants must not meet the combination specific exclusion criteria in addition to the general 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 (e.g., CTLA-4, OX 40, CD137).
- Prior allogeneic stem cell or solid organ transplantation.
- Patients with history of myocarditis.
- Presence of cardiovascular disease, as defined by:
- New York Heart Association heart failure classifications of Class II, III, or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication; or
- Transient ischemic attack or stroke within 1 year.
Who cannot join
None listed.
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-120
Ann Arbor, Michigan, 48109
- Recruiting
Site-103
Austin, Texas, 78758
- Recruiting
Site-122
Cleveland, Ohio, 44195
- Recruiting
Site-107
Denver, Colorado, 80218
- Recruiting
Site-110
Detroit, Michigan, 48201
- Recruiting
Site-115
Durham, North Carolina, 27710
- Recruiting
Site-102
Fairfax, Virginia, 22031
- Recruiting
Site-104
Houston, Texas, 77030
- Recruiting
Site-101
Irving, Texas, 75039
- Withdrawn
Site-108
Lake Mary, Florida, 32746
- Recruiting
Site-121
Miami, Florida, 33136
- Recruiting
Site-112
Myrtle Beach, South Carolina, 29572
- Recruiting
Site-116
Nashville, Tennessee, 37203
- Recruiting
Site-111
Newport Beach, California, 92663
- Recruiting
Site-118
Orlando, Florida, 32804
- Recruiting
Site-105
San Antonio, Texas, 78229
- Recruiting
Site-106
West Valley City, Utah, 84119
About this study
Official title: A Phase 1, Multicenter, Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination With Other Anti-Cancer Agents in Adult Participants With Advanced or Metastatic Solid Tumors
This is a Phase 1, first in human (FIH), Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination with Other Anti-Cancer Agents in Adult Participants with Advanced or Metastatic Solid Tumors
- Conditions
- Solid Tumor
- Being tested
- BHV-1530, Cemiplimab
- Keywords
- FGFR3-targeting ADC, antibody-drug conjugate, FGRF3, ADC, FGFR3 alteration, advanced cancers, cemiplimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-1530Drug
Also called AMB302
BHV-1530 will be administered as an IV infusion on Day 1 of each 21-day cycle
CemiplimabDrug
cemiplimab (350 mg) will be administered as an IV infusion on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| BHV-1530 Monotherapy | Experimental | Not described Receives: Drug: BHV-1530 |
| Experimental: BHV-1530 in combination with Cemiplimab | Experimental | Not described Receives: Drug: BHV-1530; Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-escalation and Dose-expansion Cohorts: To determine the safety profile, maximum tolerable dose (MTD), minimally reproducible active dose (MRAD), and recommended dose range (RDR) of BHV-1530 monotherapy and BHV-1530 in combination with cemiplimab
Incidence and severity of TEAEs, including DLTs, SAEs and change from baseline for laboratory values, electrocardiograms (ECGs), vital signs, and physical exams to determine the safety profile, MTD, MRAD and RDR of BHV-1530 monotherapy and in combination with cemiplimab.
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Recommended dose of BHV-1530 for later phase trials
Incidence and severity of treatment-emergent AEs and SAEs, changes between baseline and postbaseline in laboratory values, ECGs, vital signs, and physical exams.
Measured: Through study completion, estimated as an average of 48 months
Secondary outcomes (25)
Dose-escalation and Dose-expansion Cohorts: Clinical Benefit Rate (CBR)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Objective Response Rate (ORR)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Disease Control Rate (DCR)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Time to Response (TTR)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Duration of Response (DOR)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Progression-free Survival (PFS)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Maximum observed serum concentration (Cmax)
Serum concentration of BHV-1530, total antibody and TopoIx BHV-0080269
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Time of maximum concentration (Tmax)
Time of maximum concentration of BHV-1530, total antibody and TopoIx BHV-0080269
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Elimination half-life (t½)
Terminal elimination half-life (t½) of BHV-1530, total antibody and TopoIx BHV-0080269
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Area Under the Concentration versus time curve (AUC)
Area under the concentration-time curve from zero to last quantifiable concentration (AUC0-t) and AUC extrapolated to infinity (AUC0-inf) and AUC over the dosing interval (AUCtau)
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Trough concentration (Ctrough)
Trough concentration of BHV-1530, total antibody and TopoIx BHV-0080269
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Total body clearance (CL)
Total body clearance of BHV-1530 and total antibody
Measured: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Volume of distribution at steady state (Vss)
Volume of distribution of BHV-1530 and total antibody
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Objective Response Rate (ORR)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Disease Control Rate (DCR)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Time to Response (TTR)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Duration of Response (DOR)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Progression-free Survival (PFS)
Assessed by RECIST v 1.1
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Maximum observed serum concentration (Cmax)
Serum concentration of BHV-1530, total antibody and free payload TopoIx BHV-0080269
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Time of maximum concentration (Tmax)
Time of maximum concentration of BHV-1530, total antibody and TopoIx BHV-0080269
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Elimination half-life (t½) of BHV-1530
Terminal elimination half-life (t½) of BHV-1530, total antibody and TopoIx BHV-0080269
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Area Under the Concentration versus time curve (AUC)
Area under the concentration-time curve from zero to last quantifiable concentration (AUC0-t) and AUC extrapolated to infinity (AUC0-inf) and AUC over the dosing interval (AUCtau)
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Trough concentration (Ctrough)
Trough concentration of BHV-1530, total antibody and TopoIx BHV-0080269
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Total body clearance (CL)
Total body clearance of BHV-1530 and total antibody
Measured: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Volume of distribution at steady state (Vss)
Volume of distribution of BHV-1530 and total antibody
Measured: Through study completion, estimated as an average of 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start20 Mar 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874335
- Sponsor's protocol ID
- BHV1530-101
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination With Other Anti-Cancer Agents in Adult Participants With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06874335
- Acronym / sponsor ID
- BHV1530-101
- Conditions
- Solid Tumor
- Keywords
- FGFR3-targeting ADC, antibody-drug conjugate, FGRF3, ADC, FGFR3 alteration, advanced cancers, cemiplimab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 13 Mar 2025 (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, first in human (FIH), Open-Label, Dose Escalation, Dose Expansion and Dose Optimization Study of BHV-1530 as Monotherapy and in Combination with Other Anti-Cancer Agents in Adult Participants with Advanced or Metastatic Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHV-1530 Monotherapy | Experimental | Drug: BHV-1530 |
| Experimental: BHV-1530 in combination with Cemiplimab | Experimental | Drug: BHV-1530, Drug: Cemiplimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (69 listed)
- Signed, written Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved informed consent
- Age greater than or equal to 18 years
- Participants consent to provide tumor tissue collected prior to study treatment, preferably from a biopsy performed after their last anticancer therapy and within 90 days of the start of study treatment. An older archival sample may be acceptable with Sponsor approval.
- Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy.
- Patients with histologically or cytologically confirmed locally advanced/metastatic relapsed or refractory solid tumors as outlined below:
Key exclusion criteria (0 listed)
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-1530Also: AMB302BHV-1530 will be administered as an IV infusion on Day 1 of each 21-day cycle | Drug | BHV-1530 Monotherapy, Experimental: BHV-1530 in combination with Cemiplimab |
| Cemiplimabcemiplimab (350 mg) will be administered as an IV infusion on Day 1 of each 21-day cycle | Drug | Experimental: BHV-1530 in combination with Cemiplimab |
Primary outcome
Dose-escalation and Dose-expansion Cohorts: To determine the safety profile, maximum tolerable dose (MTD), minimally reproducible active dose (MRAD), and recommended dose range (RDR) of BHV-1530 monotherapy and BHV-1530 in combination with cemiplimab
Time frame: Through study completion, estimated as an average of 48 months
Incidence and severity of TEAEs, including DLTs, SAEs and change from baseline for laboratory values, electrocardiograms (ECGs), vital signs, and physical exams to determine the safety profile, MTD, MRAD and RDR of BHV-1530 monotherapy and in combination with cemiplimab.
Dose-optimization Cohorts: Recommended dose of BHV-1530 for later phase trials
Time frame: Through study completion, estimated as an average of 48 months
Incidence and severity of treatment-emergent AEs and SAEs, changes between baseline and postbaseline in laboratory values, ECGs, vital signs, and physical exams.
25 secondary outcomes
Dose-escalation and Dose-expansion Cohorts: Clinical Benefit Rate (CBR)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Objective Response Rate (ORR)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Disease Control Rate (DCR)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Time to Response (TTR)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Duration of Response (DOR)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Progression-free Survival (PFS)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Maximum observed serum concentration (Cmax)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Time of maximum concentration (Tmax)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Elimination half-life (t½)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Area Under the Concentration versus time curve (AUC)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Trough concentration (Ctrough)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Total body clearance (CL)
Time frame: Through study completion, estimated as an average of 48 months
Dose-escalation and Dose-expansion Cohorts: Volume of distribution at steady state (Vss)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Objective Response Rate (ORR)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Disease Control Rate (DCR)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Time to Response (TTR)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Duration of Response (DOR)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Progression-free Survival (PFS)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Maximum observed serum concentration (Cmax)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Time of maximum concentration (Tmax)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Elimination half-life (t½) of BHV-1530
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Area Under the Concentration versus time curve (AUC)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Trough concentration (Ctrough)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Total body clearance (CL)
Time frame: Through study completion, estimated as an average of 48 months
Dose-optimization Cohorts: Volume of distribution at steady state (Vss)
Time frame: Through study completion, estimated as an average of 48 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 9 Jul 2026.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BHV-1530 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 69 inclusion and 0 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 9 Jul 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 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.
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?
Dose-escalation and Dose-expansion Cohorts: To determine the safety profile, maximum tolerable dose (MTD), minimally reproducible active dose (MRAD), and recommended dose range (RDR) of BHV-1530 monotherapy and BHV-1530 in combination with cemiplimab (time frame: Through study completion, estimated as an average of 48 months). The study lists 2 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 9 Jul 2026.