[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biohaven Therapeutics Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":240},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,80,104,131,160,190,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100641998","phase-3-study-to-determine-if-bhv-1300-is-effective-and-safe-in-adults-with-graves-disease-100641998",false,"NCT07661056","Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease","A Phase 3, Double-blind, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BHV-1300 in the Treatment of Adults With Graves' Disease","Key Inclusion Criteria:\n\n1. Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies\n2. Participants must have active hyperthyroidism due to Graves' disease\n\nKey Exclusion Criteria:\n\n1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter)\n2. History of treatment with radioactive iodine or thyroid surgery.\n3. Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline\u002FDay 1 Visit.\n4. Thyroid storm, i.e. severe thyrotoxicosis with evidence of systemic decompensation (e.g., Burch-Wartkofsky Point Scale of ≥ 45 or Japanese Thyroid Association category 1 or 2, with accompanying manifestations including hyperpyrexia, tachycardia, arrhythmias, congestive heart failure, agitation, delirium, psychosis, stupor, and coma, as well as nausea, vomiting, diarrhea, or hepatic failure) within 6 weeks of Screening.\n5. Have autoimmune disease other than Graves' disease requiring treatment\n6. Have moderate to severe thyroid eye disease (TED) and are expected to require immediate surgical intervention and\u002For are planning corrective surgery\u002Firradiation or medical therapy for TED during study participation.\n7. Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline\u002FDay 1 or throughout the study.","ALL","18 Years","70 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid",[27],"Graves Disease",[29],"Hyperthyroidism","RECRUITING","2026-06-29",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2026-06-26",{"date":38,"type":21},"2028-02",{"name":40,"class":41},"Biohaven Therapeutics Ltd.","INDUSTRY",5,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100597145","phase-1-study-of-bhv-1400-in-iga-nephropathy-100597145","NCT07054684","Study of BHV-1400 in IgA Nephropathy","An Open-Label Biomarker Study of BHV-1400 in IgA Nephropathy","Key Inclusion Criteria:\n\n1\\. Participants must have biopsy-confirmed IgA Nephropathy\n\nKey Exclusion Criteria:\n\n1. Any secondary IgAN\n2. Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause","65 Years",{"count":52,"type":21},20,[54],"PHASE1","The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).",[57],"IgA Nephropathy",[59,60,61,62,63,64,65,66,67,68,69,70],"IgAN","proteinuria","glomerulonephropathy","chronic kidney disease","kidney disease","CKD","nephritis","urologic disease","glomerulonephritis","Glomerular disease","Iga nephropathy","renal disease","2026-06-19",{"date":73,"type":34},"2026-06-23",{"date":75,"type":34},"2025-07-30",{"date":77,"type":21},"2027-07",{"name":40,"class":41},15,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100643535","phase-3-a-study-to-determine-if-bhv-1400-is-effective-and-safe-in-adults-with-iga-nephropathy-100643535","NCT07642050","A Study to Determine if BHV-1400 is Effective and Safe in Adults With IgA Nephropathy","A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BHV-1400 in the Treatment of IgA Nephropathy","Key Inclusion Criteria:\n\n* Diagnosis of IgAN as confirmed by renal biopsy conducted within 10 years prior to Screening.\n\n  * If a participant has a history of diabetes, the biopsy must have been conducted within 2 years prior to Screening with no evidence of diabetic nephropathy.\n  * In all cases, if a historical biopsy report is not available, a biopsy may be performed prior to Screening.\n* UPCR ≥ 0.75 g\u002Fg or UPE ≥ 1.0 g\u002Fd determined via 24 hour collection.\n* eGFR ≥ 30 mL\u002Fmin\u002F1.73m2 (CKD-EPI equation).\n* Participants must have been on supportive care including a stable dose regimen of ACEi or ARB (at the locally approved maximal daily dose or the maximally tolerated dose per Investigators' judgment) for at least 90 days prior to Screening. Subjects who are not able to tolerate ACEi or ARB therapy may be eligible for participation in the trial if their overall management including blood pressure control is as per local applicable guidelines. This must be discussed with the medical monitor and documented by the Investigator.\n* Patients may be on a dual endothelin angiotensin receptor antagonist (DEARA) or endothelin receptor antagonist (ERA) but must be on a stable dose for at least 90 days prior to Screening and they must remain on a stable dose throughout the course of the study. Participants may be on a sodium-glucose cotransporter 2 (SGLT2) inhibitor, mineralocorticoid receptor antagonist (including Finerenone), but must be on a stable dose for 90 days prior to Screening and must remain on a stable dose throughout the course of the study.\n\nKey Exclusion Criteria:\n\n* Any secondary IgAN as defined by the Investigator; secondary IgAN can be associated with cirrhosis, celiac disease, HIV infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, familial Mediterranean fever, etc. NOTE: IgA Vasculitis excluded if patient has had any IgA Vasculitis related extrarenal signs or symptoms, or requirement for steroid or other immunosuppressive therapy in the past year.\n* Any cause of chronic kidney disease that is not diagnosed as IgAN or may be due to non-IgAN cause, such as diabetic nephropathy. If presence of other kidney disease or concurrent glomerulopathies felt to be non-dominant, consideration for inclusion must be discussed with and approved by the Sponsor Medical Monitor\u002FSponsor Designee.\n* Presence of rapidly progressive glomerulonephritis as defined by 50% decline in eGFR within 3 months prior to Screening.\n* Evidence of nephrotic syndrome, defined as 24-hour protein \\> 3.5g with concurrent hypoalbuminemia (Albumin \\\u003C 3.0 g\u002Fdl), within 6 months of Screening\n* End-stage renal disease requiring dialysis or transplantation",{"count":88,"type":21},420,[24],"The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.",[57],[59,93,94,60,61,64,65,66,67,68,69,70,63],"Chronic Kidney disease","Nephropathy","NOT_YET_RECRUITING","2026-06-08",{"date":98,"type":34},"2026-06-11",{"date":100,"type":21},"2026-06",{"date":102,"type":21},"2029-10",{"name":40,"class":41},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100591455","phase-1-study-of-bhv-1300-in-graves-disease-100591455","NCT06980649","Study of BHV-1300 in Graves' Disease","An Open-Label Biomarker Study of BHV-1300 in Graves' Disease","Key Inclusion Criteria:\n\n1\\. Participants must have serologically confirmed Graves' Disease.\n\nKey Exclusion Criteria:\n\n1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) and\u002For history of thyroid storm within six weeks of the Baseline visit.\n2. History of treatment with radioactive iodine or thyroid surgery.",{"count":79,"type":21},[54],"The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.",[27],[116,117,118,119,120,121],"Autoimmune thyroid disease","hyperthyroidism","anti thyroid drug","thyroid disease","autoimmune diseases","endocrine system diseases","2026-05-19",{"date":124,"type":34},"2026-05-22",{"date":126,"type":34},"2025-08-21",{"date":128,"type":21},"2027-09",{"name":40,"class":41},17,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100583285","phase-1-a-phase-1-study-of-bhv-1530-in-advanced-solid-tumors-100583285","NCT06874335","A Phase 1 Study of BHV-1530 in Advanced Solid Tumors","A Phase 1, Multicenter, Open-Label, Dose Escalation, Dose Expansion and Dose Confirmation Study of BHV-1530 in Adult Patients With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Signed, written Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB)-approved informed consent\n2. Age greater than or equal to 18 years\n3. 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.\n4. Participants must have progressed following, are intolerant of, or have no available standard-of-care therapy.\n5. Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic relapsed or refractory solid tumors as outlined below:\n\n   * Dose-escalation and Dose-expansion (Backfill) Cohorts:\n\n     * 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) regardless of the presence of an activating FGFR3 alteration (mutation, fusion, or amplification) or high FGFR3 protein or mRNA expression in the absence of a detectable genetic alteration.\n     * Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation, fusion, or amplification) or high FGFR3 protein or mRNA expression in the absence of a detectable genetic alteration.\n   * Dose Confirmation Cohort:\n\n     * 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) regardless of the presence of an activating FGFR3 alteration (mutation, fusion, or amplification) or high FGFR3 protein or mRNA expression in the absence of a detectable genetic alteration.\n     * Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation, fusion, or amplification) or high FGFR3 protein or mRNA expression in the absence of a detectable genetic alteration, as determined by a validated assay performed in a CLIA certified local or central laboratory.\n6. Measurable advanced or metastatic tumors per RECIST 1.1 criteria\n7. Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n8. Acceptable liver function:\n\n   * Bilirubin ≤ 1.5 × upper limit of normal (ULN). Participants with known Gilbert's syndrome who have total bilirubin level ≤3×ULN may be enrolled.\n   * AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN (if liver metastases are present, then ≤ 5 × ULN is allowed)\n9. Acceptable renal function:\n\n   • Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL\u002Fmin 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\n10. Acceptable hematologic status:\n\n    * Blood transfusion or growth factor support is not allowed within 7 days prior to blood samples that will be used to establish eligibility\n    * Absolute neutrophil count greater than or equal to 1500\u002Fmm3. Participants with known Duffy null phenotype who have absolute neutrophil count ≥ 1,200\u002Fmm3 may be enrolled\n    * Platelet count greater than or equal to 100,000 mm3\n    * Hemoglobin greater than or equal to 9 g\u002FdL\n    * Activated partial thromboplastin time (aPTT) ≤1.5×ULN. Study participants on therapeutic doses of anticoagulation medication must have INR and\u002For aPTT ≤ the upper limit of the therapeutic range for intended use\n11. A negative urine or serum pregnancy test (if a woman of childbearing potential);\n12. 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.\n\nExclusion Criteria:\n\n1. 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.\n2. Participant has clinically significant intercurrent disease including, but not limited to:\n\n   * New York Heart Association Class III or IV heart failure\n   * Myocardial infarction, unstable angina, or stroke ≤ 6 months prior to C1D1\n   * Newly diagnosed thromboembolic events that require therapeutic intervention over the last 6 months prior to C1D1 (participants with stable control of lower limb deep venous thrombosis over at least 3 months are allowed)\n   * Severe aortic stenosis\n   * Uncontrolled arrhythmia\n   * Symptomatic pericardial effusion\n   * Congenital long QT syndrome\n   * A mean of Fredericia's formula-QT corrected interval (QTcF) prolongation to \\>470 msec based on a 12-lead ECG\n   * Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥110 mmHg) or diabetes (hemoglobin A1C ≥9.0%)\n   * Left ventricular ejection fraction (LVEF) \\\u003C45% determined by echocardiogram or multiple gated acquisition scan (MUGA)\n   * Symptomatic pleural effusion (\\\u003C90% oxygen saturation)\n3. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n4. Primary central nervous system (CNS) tumors, current or previously treated leptomeningeal disease or known active brain metastases.\n\n   NOTE: Participants with previously treated, clinically stable, radiologically stable brain metastases maybe eligible\n5. Pregnant or nursing women\n6. 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\n7. 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\n8. Any clinically significant corneal or retinal abnormality that may increase the risk of eye toxicity\n9. 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:\n\n   * 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\n   * 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\u002FμL and no history of an AIDS-defining illness are eligible for entry\n10. 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\n11. Participants who in the opinion of the Investigator will not be able to adhere to the schedule of assessments and\u002For may have difficulties complying with the treatment regimen or are unwilling or unable to comply with procedures required in this protocol\n12. Known sensitivity to BHV-1530 or any of the excipients in BHV-1530;\n13. History of (noninfectious) clinically significant interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, active clinically significant ILD\u002Fpneumonitis, or suspected clinically significant ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n14. Requires supplemental oxygen for daily activities\n15. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment",{"count":139,"type":21},95,[54],"This is a Phase 1, first in human (FIH), open-label, multicenter study of BHV-1530 in adult participants with advanced or metastatic solid tumors.",[143],"Solid Tumor",[145,146,147,148,149,150],"FGFR3-targeting ADC","antibody-drug conjugate","FGRF3","ADC","FGFR3 alteration","advanced cancers","2026-05-11",{"date":153,"type":34},"2026-05-13",{"date":155,"type":34},"2025-03-20",{"date":157,"type":21},"2029-03",{"name":40,"class":41},13,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},"100526296","phase-2-a-study-to-determine-if-bhv-7000-is-effective-and-safe-in-adults-with-refractory-focal-onset-epilepsy-100526296","NCT06132893","A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy","A Phase 2\u002F3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy","RISE 2","Key Inclusion Criteria:\n\n1. Male and Female participants 18 to 75 years of age at time of consent.\n2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.\n\n   a. Focal seizures i. Focal aware seizures with clinically observable signs and\u002For symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures\n3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.\n4. Ability to keep accurate seizure diaries\n5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total\n\nKey Exclusion Criteria:\n\n1. History of status epilepticus (convulsive status epilepticus for \\> 5 minutes or focal status epilepticus with impaired consciousness for \\> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.\n2. History of repetitive\u002Fcluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.\n3. Resection neurosurgery for seizures \\\u003C4 months prior to the screening visit.\n4. Radiosurgery performed \\\u003C2 years prior to the screening visit.\n5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.\n6. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and\u002For confound the interpretation of safety or efficacy data from the study, as judged by the Investigator","75 Years",{"count":170,"type":21},390,[172,24],"PHASE2","The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.",[175],"Focal Epilepsy",[175,177,178,179,180],"Epilepsy","Seizure","Refractory Epilepsy","Partial Epilepsy","2026-04-30",{"date":183,"type":34},"2026-05-01",{"date":185,"type":34},"2024-03-14",{"date":187,"type":21},"2026-12",{"name":40,"class":41},124,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":212,"locationsCount":130},"100545661","phase-1-a-phase-12-study-of-bhv-1510-previously-pbi-410-in-advanced-solid-tumors-100545661","NCT06384807","A Phase 1\u002F2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors","A Phase 1\u002F2, 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","Key Inclusion Criteria:\n\n* Male or female participants aged ≥18 years.\n* 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.\n* Measurable disease (per RECIST 1.1).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n* 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):\n\n  * Hemoglobin ≥9 g\u002FdL\n  * Absolute neutrophil count \\>1,500\u002Fmm3; participants with known Duffy null phenotype who have absolute neutrophil count ≥1,200\u002Fmm3 may be enrolled\n  * Platelets \\>100,000\u002Fmm3\n  * Creatinine clearance ≥50 mL\u002Fmin measured or estimated using the Cockcroft-Gault formula; 24-hour urine collection is allowed, but not required.\n  * 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.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C2.5×ULN (or ≤5×ULN for participants with hepatic metastases)\n  * Alkaline phosphatase \\\u003C2.5×ULN (or ≤5×ULN for participants with hepatic and\u002For bone metastases)\n  * International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN\n  * Activated partial thromboplastin time (aPTT) ≤1.5×ULN. Study participants on therapeutic doses of anticoagulation medication must have INR and\u002For aPTT ≤ the upper limit of the therapeutic range for intended use\n* Have recovered (ie, improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and vitiligo.\n\nBHV-1510 in Combination with specific inclusion criteria:\n\n* 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)\n* 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\u002F metastatic disease.\n\nKey Exclusion Criteria:\n\n* Women who are pregnant or lactating.\n* Clinically significant intercurrent disease.\n* Has symptomatic brain metastases or has had any radiation or surgery for brain metastases within 4 weeks of C1D1.\n* Has clinically significant corneal disease.\n* Requires supplemental oxygen for daily activities.\n* Previous treatment with a Trop-2-targeted therapy, including Trop-2 ADCs.\n* 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.\n* 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.\n* History of severe hypersensitivity reactions to other monoclonal antibodies or either the drug substances or inactive ingredients of BHV-1510.\n* Has current or previously treated leptomeningeal carcinomatosis.\n* Use of OAP1B1 and OATP1B3 inhibitors within 14 days prior to starting trial.\n\nBHV-1510 in Combination Specific Exclusion Criteria:\n\n* Hypersensitivity to cemiplimab or any of its excipients or contraindicated to cemiplimab per approved local labeling.\n* 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).\n* Prior allogeneic stem cell or solid organ transplantation.\n* Patients with history of myocarditis.\n* Presence of cardiovascular disease",{"count":198,"type":21},500,[54,172],"This is a Phase 1\u002F2, 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.",[143],[203,204,205,148],"Trop2 targeting ADC","Antibody-drug conjugate","Trop2","2026-03-09",{"date":208,"type":34},"2026-03-11",{"date":210,"type":34},"2024-04-22",{"date":38,"type":21},{"name":40,"class":41},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":220,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":239,"locationsCount":79},"100591118","phase-2-a-study-to-determine-if-bhv-8000-is-effective-safe-and-tolerable-as-a-treatment-for-adults-living-with-early-parkinsons-disease-100591118","NCT06976268","A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease","A Phase 2\u002F3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease","Key Inclusion Criteria:\n\n* Male or female participants 40 to 85 years of age, inclusive, at the time of informed consent.\n* Meet the diagnostic criteria for \"Probable PD\" as assessed on the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator.\n* Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 years of the Screening Visit\n\nKey Exclusion Criteria:\n\n* Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including, but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced Parkinsonism, essential tremor, or primary dystonia.\n* Diagnosis of clinically significant central nervous system (CNS) disease other than PD.\n* Participants who are current smokers (defined as smoking \\[in any form, e.g., tobacco smoke, electronic cigarettes, etc.\\] )\n* Treatment with PD medication(s)\n* Any other condition(s) that may compromise participant safety, interfere with study conduct, or jeopardize the potential proper interpretation of study results, in the opinion of the investigator.","40 Years","85 Years",{"count":223,"type":21},550,[172,24],"A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.",[227],"Parkinson Disease",[229,230,231,232],"Early Parkinson's Disease","Parkinson's Disease","Early onset Parkinson's Disease","treatment naiive early Parkinson's Disease","2026-01-13",{"date":235,"type":34},"2026-01-14",{"date":237,"type":34},"2025-05-28",{"date":128,"type":21},{"name":40,"class":41},""]