[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Calico Life Sciences LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,81,108],{"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":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100497430","phase-1-an-open-label-exploratory-study-of-fosigotifator-in-participants-with-vanishing-white-matter-disease-100497430",false,"NCT05757141","An Open-Label Exploratory Study of Fosigotifator in Participants With Vanishing White Matter Disease","A Phase 1b\u002F2 Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy Following Fosigotifator Administration in Adult and Pediatric Subjects With Vanishing White Matter Disease","Inclusion Criteria:\n\n1. Males and females \\>= 6 months of age at the time of Screening.\n2. Have VWM disease defined as:\n\n   1. A clinical diagnosis by a physician experienced in the assessment of VWM disease; and\n   2. A molecular diagnosis of VWM disease, and\n   3. A magnetic resonance imaging (MRI) presentation consistent with VWM disease.\n3. Have a designated caregiver who is able to complete the respective caregiver-centered assessments.\n4. Signed and dated informed consent provided by the participant, or from a legally authorized representative (LAR) if participant is incapable to consent themselves.\n5. Participants must meet criteria (a) and at least one of the following functional criteria (b or c):\n\n   1. Medical history of at least 1 neurological symptom that is assessed by the investigator as having a reasonable possibility of being related to VWM disease.\n   2. Motor criteria defined as inability to walk 10 or more steps with or without light support of 2 hands\n   3. Cognitive criteria as assessed by the age-appropriate version of the Wechsler Intelligence Scale, with participants scoring \\\u003C 50 on specific indices; specific details can be provided by the Study physician.\n6. Pediatric participants in Cohort 4 must meet both criteria a and b below, or criterion c:\n\n   1. Medical history of at least 1 neurological symptom that is assessed by the investigator as having a reasonable possibility of being related to VWM disease.\n   2. Motor criteria as defined below:\n\n   i. More than minimal head control as demonstrated by: While in prone position, the participant can lift his\u002Fher head and sustain the position for 10 seconds and bring his\u002Fher arms actively to weight bearing in that position.\n\n   c. Presymptomatic and homozygous for Cree Leukoencephalopathy (EIF2B5 R195H) or other mutation with known imminent risk of significant clinical decline or death (sponsor must be notified and provide approval prior to screening and enrolling a participant that meets eligibility with only this criterion).\n7. All male participants who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male participants must agree to not donate sperm during the study until 30 days after the final dose of study drug.\n8. All female participants who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female participants must agree to not donate eggs during the study and for 30 days after the final dose of study drug.\n\nExclusion Criteria:\n\n1. Pediatric participants \\>= 6 months and \\\u003C 6 years of age must not be on any form of respiratory support at the time of Screening.\n2. Changes in medication use for the management of VWM disease symptoms within the 4 weeks preceding Screening.\n3. Seizure disorder not considered adequately controlled by the investigator within the 6 months preceding Screening.\n4. Participant who, in the opinion of the investigator, is incapable of completing study-required visits and procedures to assess primary and secondary endpoints.\n5. Adult female participants who are pregnant, breastfeeding or providing breast milk.\n6. Treatment with any other investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to Baseline.\n7. Any clinically significant laboratory or imaging findings at Screening.","ALL","6 Months",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Fosigotifator is an investigational drug being researched for the treatment of Vanishing White Matter disease in adult, pediatric and infant participants. This is a 201-week, open-label, multiple cohort study enrolling adults, pediatric and infant participants with Vanishing White Matter disease.\n\nParticipants will attend regular visits during the course of the study and complete medical assessments, blood tests, questionnaires, and be evaluated for side effects.",[27],"Vanishing White Matter Disease",[29,30,31,32,33],"Neurodegenerative Diseases","Nervous System Diseases","Central Nervous System Brain Diseases","Hereditary Central Nervous System","Leukoencephalopathy with Vanishing White Matter","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2023-03-13",{"date":42,"type":20},"2035-10",{"name":44,"class":45},"Calico Life Sciences LLC","INDUSTRY",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100422220","phase-1-study-with-abbv-cls-484-in-participants-with-locally-advanced-or-metastatic-tumors-100422220","NCT04777994","Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors","A Phase 1 Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors","Inclusion Criteria:\n\n* Must weigh at least 35 kilograms (kg).\n* An Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 2.\n* Life expectancy of \\>= 12 weeks.\n* Laboratory values meeting protocol criteria.\n* QT interval corrected for heart rate \\\u003C 470 msec (using Fridericia's correction), and no clinically significant electrocardiographic findings.\n* Measurable disease defined by RECIST 1.1 criteria.\n\nFor Monotherapy and Combination Dose Escalation:\n\n* Participants with histologically or cytologically proven metastatic or locally advanced tumors, for which no effective standard therapy exists, or where standard therapy has failed. Participants must have received at least 1 prior systemic anticancer therapy for the indication being considered.\n\nFor Monotherapy Dose Expansion only:\n\n* Participants must have received at least 1 prior line containing PD-1\u002FPD-L1 targeted therapy with a best response by RECIST v1.1 of CR\u002FPR\u002Fstable (any duration) or stable disease (for greater than 6 months); AND\n* Must have been previously treated with 1 or more prior lines of therapy in the locally advanced or metastatic setting with the following tumor types:\n\n  * Relapsed\u002Frefractory HNSCC\n  * Relapsed\u002Frefractory NSCLC\n  * Advanced ccRCC\n\nFor PD-1 Targeting Agent Combination Dose Expansion only:\n\n* For the following tumor types, subject must have received at least 1 prior line containing PD-1\u002FPD-L1 targeted therapy with response by RECIST v1.1 of CR\u002FPR (any duration) or stable disease (for greater than 6 months):\n\n  * Relapsed HNSCC\n  * Relapsed NSCLC\n  * Relapsed Advanced ccRCC\n* For the following tumor types, subject must have received at least 1 prior line containing PD-1\u002FPD-L1 targeted therapy and have had disease progression with PD-1\u002FPD-L1 targeted therapy:\n\n  * Locally Advanced or metastatic MSI-H tumors\n\nFor VEGFR TKI Combination Dose Expansion only:\n\n* Relapsed advance ccRCC with no more than 1 prior VEGFR TKI\n* Participants no recent history of hemorrhage, including hemoptysis, hematemesis, or melena\n* Participants with poorly controlled hypertension are excluded.\n\nExclusion Criteria:\n\n* Untreated brain or meningeal metastases (i.e., subjects with history of metastases are eligible provided they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 28 days after definitive therapy)\n* Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.\n* Unresolved Grade 2 or higher peripheral neuropathy.\n* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.\n* Recent history (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, pericarditis, or clinically significant pericardial effusion or arrythmia.\n* Recent history (within 6 months) of Childs-Pugh B or C classification of liver disease.\n* History of clinically significant medical and\u002For psychiatric conditions or any other reason that, in the opinion of the investigator, would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.\n* History of uncontrolled, clinically significant endocrinopathy.\n* Known gastrointestinal disorders making absorption of oral medications problematic; subject must be able to swallow capsules.\n* If treated with a PD-1\u002FaPD-L1 targeting or other immune-oncology agents in the past, excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity, hypersensitivity to administered drug or drug related toxicity requiring discontinuation.\n* Active autoimmune disease requiring systemic treatment in past 2-years (exceptions for endocrinopathies, vitiligo or atopic conditions).\n* History of solid organ transplant or allogeneic stem cell transplant.\n* History of other malignancy, with the following exceptions:\n\n  * No known active disease present within \\>= 3 years before first dose of study treatment and felt to be at low recurrence by investigator.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated carcinoma in situ without evidence of disease.\n* History of interstitial lung disease or pneumonitis.\n* Major surgery \\\u003C= 28 days prior to first dose of study drug\n* Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.","18 Years",{"count":56,"type":20},248,[23],"The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI).\n\nThe trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy).\n\nPart 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.\n\nPart 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors.\n\nPart 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1\u002FPD-L1, and advanced ccRCC.",[60],"Advanced Solid Tumor Cancer",[62,63,64,65,66,67,68,69,70,71],"Cancer","Tumor","anti-PD-1","ABBV-CLS-484","clear cell renal cell carcinoma (ccRCC)","head and neck squamous cell carcinoma (HNSCC)","non-small cell lung cancer (NSCLC)","relapsed or refractory (R\u002FR)","Microsatellite instability - high tumors (MSI-H)","Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)","2026-06-02",{"date":74,"type":38},"2026-06-04",{"date":76,"type":38},"2021-03-09",{"date":78,"type":20},"2026-10",{"name":44,"class":45},30,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100585453","phase-2-anchor-study-a-study-to-assess-the-safety-and-efficacy-of-abbv-cls-628-in-adult-participants-with-autosomal-dominant-polycystic-kidney-disease-adpkd-100585453","NCT06902558","ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABBV-CLS-628 in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)","ANCHOR","Inclusion Criteria:\n\n* Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD.\n* Estimated glomerular filtration rate (eGFR) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2 and \\\u003C 90 mL\u002Fmin\u002F1.73 m\\^2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening.\n\nExclusion Criteria:\n\n* Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.\n* Any exclusionary medical diseases, disorders, or conditions as described in the protocol.","55 Years",{"count":91,"type":20},240,[24],"Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants.\n\nABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide.\n\nParticipants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[95],"Autosomal Dominant Polycystic Kidney Disease",[97,98],"Autosomal Dominant Polycystic Kidney Disease (ADPKD)","ABBV-CLS-628","2026-05-22",{"date":101,"type":38},"2026-05-26",{"date":103,"type":38},"2025-06-09",{"date":105,"type":20},"2029-08",{"name":44,"class":45},75,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":4,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":4,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":121,"locationsCount":4},"100530607","expanded-access-to-abbv-cls-484-100530607","NCT06188975","Expanded Access to ABBV-CLS-484","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-CLS-484 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[60],"AVAILABLE","2023-12-18",{"date":120,"type":38},"2024-01-03",{"name":44,"class":45},""]