[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Arcus Biosciences, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,77,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100480450","phase-1-a-phase-1-study-of-ab521-monotherapy-and-combination-therapies-in-renal-cell-carcinoma-and-other-solid-tumors-100480450",false,"NCT05536141","A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors","ARC-20","Key Inclusion Criteria:\n\n* Must have at least one measurable lesion per RECIST guidance\n* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1\n* Disease-specific criteria for dose escalation:\n\n  * Participants may have any pathologically confirmed solid tumor type where no other treatment options are available\n  * Creatinine clearance ≥ 40 mL\u002Fmin\n\nDisease-specific criteria for dose-expansion:\n\n* Histologically confirmed ccRCC\n* Creatinine clearance ≥ 40 mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product\n* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous\n* History of trauma or major surgery within 28 days prior to the first dose of investigational product\n* For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},362,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of:\n\n* casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and\n* casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.",[27,28],"Clear Cell Renal Cell Carcinoma","Solid Tumors",[27,30,31,32,33,34,35],"AB521","Casdatifan","Kidney Cancer","Zimberelimab","AB122","Hif2a","RECRUITING","2026-07-01",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":40},"2022-10-26",{"date":44,"type":21},"2029-03",{"name":46,"class":47},"Arcus Biosciences, Inc.","INDUSTRY",25,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100644059","phase-1-a-study-to-investigate-the-safety-tolerability-and-pk-of-ab102-in-healthy-participants-100644059","NCT07662057","A Study to Investigate the Safety, Tolerability, and PK of AB102 in Healthy Participants","A Double-Blind, Randomized, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose First-In-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AB102 in Healthy Participants","Inclusion Criteria:\n\n* Understands the study procedures in the Informed Consent Form and is willing and able to comply with the protocol.\n* BMI: 19.0 to 30.0 kg\u002Fm2, inclusive, at screening.\n* All prescribed medication must have been stopped at least 30 days prior to admission to the clinical site. An exception is made for hormonal contraceptives that may be used throughout the study.\n* Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, vital signs, and complete neurological examination, as judged by the Investigator.\n* Participants must follow protocol-specified contraception guidance.\n\nExclusion Criteria:\n\n* Have a history of relevant atopy, drug hypersensitivity and\u002For food allergies.\n* Using tobacco products within 3 months prior to the screening.\n* Have a significant infection or known inflammatory process on screening or admission.\n* Have received any vaccination within 14 days of admission date for non-live vaccines or 28 days of admission date for live attenuated vaccines.\n* History of alcohol abuse or drug addiction in the last 2 years (including soft drugs like cannabis products).\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"55 Years",{"count":59,"type":21},130,[24],"The purpose of this study is assess the safety and tolerability of AB102 and characterize the pharmacokinetics (PK) profile of AB102 after single and multiple ascending oral dose(s).",[63],"Healthy Volunteers",[65,66,67],"AB102","Healthy Volunteer","MRGPRX2 inhibitor","NOT_YET_RECRUITING","2026-06-22",{"date":71,"type":40},"2026-06-25",{"date":73,"type":21},"2026-07",{"date":75,"type":21},"2026-12",{"name":46,"class":47},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":99,"locationsCount":100},"100642026","phase-1-a-bioequivalence-study-between-two-casdatifan-tablet-strengths-and-food-effect-study-of-casdatifan-in-healthy-adult-participants-100642026","NCT07641881","A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants","A Phase 1, Open-Label, Randomized, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of Two Casdatifan (AB521) Tablet Strengths and Food Effect in Healthy Adult Participants","Inclusion Criteria:\n\n* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.\n* BMI ≥ 18.0 and ≤ 32.0 kg\u002Fm2 and body weight ≥ 45 kg at the screening visit.\n* Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.\n* Able to swallow multiple tablets.\n* Has adequate peripheral venous access.\n\nExclusion Criteria:\n\n* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.\n* History of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).\n* Seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the PI or designee considers to be clinically significant.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":85,"type":21},24,[24],"The purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan 100 mg versus four 25 mg tablets under fasting conditions in healthy adult participants, and to evaluate the effect of food on the single-dose PK of casdatifan 100 mg administered as four 25 mg tablets in healthy adult participants.",[89],"Healthy Participants",[31,30,91,92],"HIF-2α","Pharmacokinetics","2026-06-16",{"date":95,"type":40},"2026-06-17",{"date":97,"type":40},"2026-05-29",{"date":73,"type":21},{"name":46,"class":47},1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100593844","phase-3-study-of-casdatifan-and-cabozantinib-versus-placebo-and-cabozantinib-in-patients-with-advanced-clear-cell-renal-cell-carcinoma-100593844","NCT07011719","Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma","A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.\n* A Karnofsky Performance Status (KPS) score ≥ 80%\n* At least 1 target lesion measurable by computed tomography\u002Fmagnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.\n* Adequate organ and marrow function, ≤ 1 week prior to randomization.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.\n\nExclusion Criteria:\n\n* Received prior treatment with a HIF-2α inhibitor or cabozantinib.\n* Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.\n* Ongoing clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.\n* Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure \\> 150 mmHg systolic or \\> 90 mmHg diastolic despite optimal antihypertensive treatment.\n* History of leptomeningeal disease or spinal cord compression.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":109,"type":21},720,[111],"PHASE3","The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.",[114,115],"Metastatic Clear Cell Renal Cell Carcinoma","Advanced Clear Cell Renal Cell Carcinoma",[31,114,115,32,117,30,118],"PEAK-1","ccRCC",{"date":120,"type":40},"2026-06-02",{"date":122,"type":40},"2025-09-08",{"date":124,"type":21},"2030-12",{"name":46,"class":47},118,""]