[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vir Biotechnology, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":157},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,80,106,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100515907","phase-1-safety-pharmacokinetics-and-preliminary-efficacy-of-vir-5500-amx-500-in-prostate-cancer-100515907",false,"NCT05997615","Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer","A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer","Inclusion Criteria:\n\nApplicable to Parts 1 and 2\n\n1. Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging\n2. Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3)\n\n   * PSA level ≥ 1 ng\u002FmL that has increased on ≥ 2 successive occasions ≥ 1 week apart\n   * Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications\n   * Appearance of ≥ 2 new lesions in bone scan\n3. Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and\u002For enzalutamide\n4. Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel)\n5. Are deemed unsuitable for standard of care\n\nApplicable to Part 2, 3a and Part 4a,\n\n1. Have metastatic CRPC, defined by ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging that has documented progressive disease (PD) based on ≥ 1 of the following criteria (per PCWG3):\n\n   * PSA level ≥ 1 ng\u002FmL that has increased on ≥ 2 successive occasions ≥ 1 week apart\n   * Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications\n   * Appearance of ≥2 new lesions in bone scan\n2. Participants with metastatic hormone sensitive prostate cancer (mHSPC) or with biochemical recurrent prostate cancer (BRPC) may also participate in select cohorts of this clinical trial.\n\nExclusion Criteria:\n\n1. Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components\n2. Has acute or chronic infections\n3. Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500 (AMX-500), per the Investigator\n4. Has lesions in proximity of vital organs\n5. Has known active CNS metastases and\u002For carcinomatous meningitis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","MALE","18 Years",{"count":19,"type":20},437,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The study will be conducted in 4 parts and will commence with dose escalation of VIR-5500 as a monotherapy (Part 1), followed by combination escalation (Part 3a), monotherapy dose expansion (Part 2) and combination dose expansion (Part 4a).\n\n* Part 1 (Monotherapy Dose Escalation): Single-agent VIR-5500 dose escalation\n* Part 2 (Monotherapy Dose Expansion): Single-agent VIR-5500 dose expansion\n* Part 3 (Combination Dose Escalation): VIR-5500 plus another therapeutic agent dose escalation Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)\n* Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion Part 4a (Combination Dose Expansion): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)",[26],"Hormone-refractory Prostate Cancer",[28,29,30,31,32],"Prostate Cancer","Castration Resistant Prostatic Cancer","High-Risk Biochemical Recurrent Prostate Cancer","Metastatic Castration-resistant Prostate Cancer (mCRPC)","Hormone Sensitive Prostate Cancer (HSPC)","RECRUITING","2026-06-03",{"date":36,"type":37},"2026-06-04","ACTUAL",{"date":39,"type":37},"2023-08-10",{"date":41,"type":20},"2027-09-29",{"name":43,"class":44},"Vir Biotechnology, Inc.","INDUSTRY",12,{"id":47,"slug":4,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100602825","NCT07128550","A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide","A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)","Inclusion Criteria:\n\n1. Male or female ages 18 to 70 years at screening\n2. HDV RNA ≥ 500 IU\u002FmL at screening\n3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1\n4. Noncirrhotic or compensated cirrhotic liver disease at screening\n5. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \\\u003C 10 IU\u002Fml at screening, currently on locally approved NRTI therapy\n\nExclusion Criteria:\n\n1. Serum ALT ≥ 5 × ULN\n2. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.\n3. History of significant liver disease from non-HBV or non-HDV etiology\n4. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.\n5. History of anaphylaxis\n6. History of immune complex disease\n7. History of autoimmune disorder\n8. Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.","ALL","70 Years",{"count":55,"type":20},150,[57],"PHASE3","This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide",[60],"Viral Hepatitis",[62,63,64,65,66,67,68,69,70],"HDV","Hepatitis D Virus","Hepatitis","Chronic Hepatitis D Virus","Hepatitis D","Hepatitis D, Chronic","Hepatitis Delta Virus","Digestive System Diseases","Liver Diseases","2026-05-04",{"date":73,"type":37},"2026-05-06",{"date":75,"type":37},"2025-07-30",{"date":77,"type":20},"2031-07",{"name":43,"class":44},38,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100589898","phase-1-safety-and-preliminary-efficacy-of-vir-5525-and-vir-5525--pembrolizumab-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100589898","NCT06960395","Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5525 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nI 01. Are ≥ 18 years of age, or at the country's legal age of majority of the legal adult age is \\>18 years, at the time of signing the ICF.\n\nI 02. Have an ECOG performance status of 0 to 1.\n\nI 03. Have a life expectancy of at least 12 weeks.\n\nI 04. Have histological, pathological, or cytological confirmation of disease type that is unresectable, locally advanced, or metastatic.\n\nI 05. Have measurable disease per RECIST v1.1 as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nI 06. Have diseases under study, lines of therapy, and biomarker status, as follows:\n\nHave one of the following:\n\n• (Parts 1 and 3): NSCLC (nonsquamous or squamous histology), CRC, HNSCC, or CSCC.\n\nNote: Participants with nasopharyngeal tumors are eligible. Note: Participants with upper esophageal or salivary gland tumors are not eligible.\n\nOR\n\n• Have a solid tumor with EGFR amplification (as previously determined locally with an analytically validated assay in a certified testing laboratory).\n\nHave no available standard systemic therapy; or standard therapy is intolerable, not effective, or not accessible; or participant has refused standard therapy.\n\nExclusion Criteria:\n\nE 01. Are a WOCBP with a positive serum or urine pregnancy test within 72 hours prior to treatment.\n\nE 02. Have acute or chronic infections, including the following:\n\n* Acute or chronic active Epstein-Barr virus (EBV) infection (Exception: asymptomatic EBV-positive participants are still eligible)\n* Chronic active EBV disease defined as a chronic illness lasting at least 6 months, an increased EBV level in either the tissue or the blood, and lack of evidence of a known underlying immunodeficiency\n* History of hepatitis B infection (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) infection (defined as HCV \\[HCV RNA; qualitative\\] is detected)\n* History of HIV infection. No HIV testing is required unless mandated by the local health authority.\n* Active infection requiring systemic therapy within 14 days of Cycle 1 Day 1\n* Known positive COVID-19 test result at screening (Exception: If follow-up test is negative, participants may be eligible if asymptomatic and upon consultation with medical monitor)\n\nE 03. Have a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5525 or pembrolizumab, per the investigator\n\nE 04. Have a QT interval corrected by Fridericia's method (QTcF) that is \\>480 ms\n\nE 05. Have received prior systemic anti-cancer therapy, including investigational agents, within 5 half-lives prior to first dose of study intervention. For drugs with a long t1\u002F2, such as mAbs, or for drugs for which the t1\u002F2 is not known, the last dose should not have been within 28 days prior to first dose of study intervention.\n\nNote: If the participant has had major surgery, the participant must have recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention.\n\nE 06. Have received prior radiotherapy within 2 weeks of start of study intervention Note: Participants must have recovered from all radiation-related toxicities to Grade ≤1 or baseline, must not require corticosteroids, and must not have had radiation pneumonitis.\n\nException: External beam radiotherapy, including palliative external radiation, is allowed.\n\nA 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",{"count":88,"type":20},450,[23],"This Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR.\n\nThe study will be conducted in the following 4 parts:\n\n* Part 1: VIR-5525 monotherapy dose escalation\n* Part 2: VIR-5525 monotherapy dose expansion\n* Part 3: VIR-5525 plus pembrolizumab dose escalation\n* Part 4: VIR-5525 plus pembrolizumab dose expansion",[92,93,94],"Solid Tumor Malignancies","EGFR Positive Solid Tumors","EGFR",[96],"VIR-5525","2026-04-10",{"date":99,"type":37},"2026-04-13",{"date":101,"type":37},"2025-07-22",{"date":103,"type":20},"2029-08",{"name":43,"class":44},4,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100466669","phase-1-to-access-the-safety-and-effects-of-intravenous-administration-of-vir-5818-alone-and-in-combination-with-pembrolizumab-in-adult-participants-with-locally-advanced-or-metastatic-her2-expressing-cancers-100466669","NCT05356741","To Access the Safety and Effects of Intravenous Administration of VIR-5818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers","A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of VIR-5818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers","Inclusion criteria:\n\n* Written informed consent by the participant (or legally acceptable representative if applicable)\n* Life expectancy of at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Diseases under study, prior lines of therapy, and human epidermal growth factor receptor 2 (HER2) status, per local tests\n\nExclusion criteria:\n\n* Significant cardiopulmonary disease and recent cardiac events\n* History of major organ autoimmune diseases\n* Acute or chronic infections\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",true,{"count":115,"type":20},645,[23,117],"PHASE2","This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of VIR-5818 (Formerly AMX-818) as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts:\n\n* Part 1 (dose escalation): Single-agent VIR-5818\n* Part 2 (dose escalation): VIR-5818 plus pembrolizumab\n* Part 3 (dose expansion): Single-agent VIR-5818\n* Part 4 (dose expansion): VIR-5818 plus pembrolizumab\n\nThe total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 52 months.",[120],"Locally Advanced or Metastatic HER2-Expressing Cancers","2025-09-19",{"date":123,"type":37},"2025-09-24",{"date":125,"type":37},"2022-04-13",{"date":127,"type":20},"2027-08-16",{"name":43,"class":44},10,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":113,"sex":52,"minAge":17,"maxAge":53,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":5},"100476459","phase-1-effect-of-hepatic-impairment-on-the-pharmacokinetics-and-safety-of-vir-2218-and-vir-3434-100476459","NCT05484206","Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434","A Phase 1 Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Monotherapy and Combination Therapy in Adult Participants With Hepatic Impairment","Inclusion Criteria:\n\n* Must be ≥18 to ≤70 years of age at screening\n* Must have a calculated BMI from 18.5 ≤ BMI ≤ 40 kg\u002Fm2\n* All participants must have an eGFR ≥ 60 mL\u002Fmin as calculated by the Modification of Diet in Renal Disease (MDRD) equation\n\nInclusion criteria: Healthy matched participants\n\n* Must in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations\n\nInclusion criteria: Hepatic impaired participants\n\n* Apart from hepatic insufficiency, participants must, in the opinion of the Investigator be sufficiently healthy for study participation based on medical history, physical examination, vital signs, and screening laboratory evaluations\n* Participant is considered to have chronic, stable moderate, severe, mild HI (of any etiology excluding chronic HBV and HDV) and has been clinically stable per Investigator assessment for at least 1 month prior to screening\n* CPT score of 5 to 6 for mild HI at screening\n* CPT score 7-9 for moderate HI at screening\n* CPT score 10-15 severe HI at screening\n\nExclusion Criteria:\n\n* Participants with unstable cardiac function or evidence of previous myocardial infarction in the past 12 months or any clinically significant active cardiovascular disease that, in the opinion of the Investigator, could interfere with the safety of the participant\n* Any clinically significant conduction abnormality or arrhythmia (including non-sustained or sustained ventricular tachycardia as per Investigator's assessment)\n* Infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), HBV (positive HBsAg or positive hepatitis B core antibody with negative hepatitis B surface antibody), hepatitis C virus (HCV), HDV or hepatitis E virus (HEV). HCV antibody positive participants with a negative HCV RNA are eligible. HDV antibody positive participants with a negative HDV RNA are eligible\n\nExclusion criteria: Healthy matched participants\n\n* Systolic BP is outside the range of 90-160 mmHg, or diastolic BP is outside the range of 45-95 mmHg or heart rate is outside the range of 50-100 beats per minute (bpm) for female participants or 45-100 bpm for male participants at screening\n* Use of any prescription medications or over-the-counter medications (with the exception of vitamins and\u002For hormonal contraceptive medication) within 30 days prior to D1 of study participation\n\nExclusion criteria: Participants with Hepatic impairment\n\n* Not on stable dose and regimen of any medication\n* Acute or worsening chronic hepatitis\n* Participants requiring paracentesis more than once a month\n* Participants with refractory encephalopathy or significant Central Nervous System\n* History of gastric or esophageal variceal bleeding within the past 6 months\n* Participants with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement\n* Presence of hepatopulmonary or hepatorenal syndrome\n* Presence of primarily cholestatic liver diseases\n* History of or currently listed for liver transplantation",{"count":138,"type":20},144,[23],"In this study, a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of VIR-2218 and VIR-3434 in participants with cirrhosis and Hepatic Impairment, defined using the Child-Pugh-Turcotte (CPT) categorization.",[142,143],"Hepatic Impairment","Cirrhosis",[145,146,62,147,148],"siRNA","Monoclonal antibody","Compensated Cirrhosis","Decompensated Cirrhosis","2025-06-10",{"date":151,"type":37},"2025-06-13",{"date":153,"type":37},"2022-09-21",{"date":155,"type":20},"2027-04-30",{"name":43,"class":44},""]