[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528941":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":50,"centralContacts":54,"locations":60,"responsibleParty":132,"collaborators":41,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":41,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":41,"enrollmentInfo":143,"targetDuration":41,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":41,"overallStatus":63,"whyStopped":41,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,14,18,22,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: GS-0201 Monotherapy Dose Escalation","EXPERIMENTAL","Participants will receive escalating doses of GS-0201 monotherapy, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first.",[13],"Drug: GS-0201",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B: Cohort B1: GS-0201 Monotherapy Dose Expansion","Participants with selected breast cancer indication will receive GS-0201 monotherapy at the recommended dose for expansion.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion","Participants with selected indications not included in cohort B1 will receive GS-0201 monotherapy at the recommended dose for expansion.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG)","Participants will receive escalating doses of GS-0201 in combination with SG, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first.",[13,26],"Drug: Sacituzumab Govitecan",{"label":28,"type":10,"description":29,"interventionNames":30},"Part D: Cohort D1: Dose Expansion: GS-0201 + SG","Participants with confirmed unresectable locally advanced or metastatic triple negative breast cancer (mTNBC) will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG.",[13,26],{"label":32,"type":10,"description":33,"interventionNames":34},"Part D: Cohort D2: Dose Expansion: GS-0201 + SG","Participants with recurrent\u002Fpersistent endometrial cancer will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG.",[13,26],[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","GS-0201","Pill administered orally",[9,15,19,23,28,32],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Sacituzumab Govitecan","Administered intravenously",[23,28,32],[47,48,49],"IMMU-132","Trodelvy™","GS-0132",[51],{"name":52,"affiliation":5,"role":53},"Gilead Study Director","STUDY_DIRECTOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":41,"email":59},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[61,75,85,94,103,114,123],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":41},"Dana-Farber Cancer Institute","RECRUITING","Boston","Massachusetts","02459","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-71.05977,42.35843,{"lat":73,"lon":72},{"facility":76,"status":63,"city":77,"state":78,"zip":79,"country":67,"countryCode":68,"cosmosGeoPoint":80,"geoPoint":84,"contacts":41},"NEXT Austin","Austin","Texas","78758",{"type":70,"coordinates":81},[82,83],-97.74306,30.26715,{"lat":83,"lon":82},{"facility":86,"status":63,"city":87,"state":78,"zip":88,"country":67,"countryCode":68,"cosmosGeoPoint":89,"geoPoint":93,"contacts":41},"The University of Texas MD Anderson Cancer Center","Houston","77030",{"type":70,"coordinates":90},[91,92],-95.36327,29.76328,{"lat":92,"lon":91},{"facility":95,"status":63,"city":96,"state":78,"zip":97,"country":67,"countryCode":68,"cosmosGeoPoint":98,"geoPoint":102,"contacts":41},"NEXT Dallas","Irving","75039",{"type":70,"coordinates":99},[100,101],-96.94889,32.81402,{"lat":101,"lon":100},{"facility":104,"status":63,"city":105,"state":41,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":113,"contacts":41},"Rambam Health Care Campus","Haifa","31096","Israel","IL",{"type":70,"coordinates":110},[111,112],34.99928,32.81303,{"lat":112,"lon":111},{"facility":115,"status":63,"city":116,"state":41,"zip":117,"country":107,"countryCode":108,"cosmosGeoPoint":118,"geoPoint":122,"contacts":41},"Tel Aviv Sourasky Medical Center","Tel Aviv","6423906",{"type":70,"coordinates":119},[120,121],34.78057,32.08088,{"lat":121,"lon":120},{"facility":124,"status":63,"city":125,"state":41,"zip":126,"country":107,"countryCode":108,"cosmosGeoPoint":127,"geoPoint":131,"contacts":41},"Chaim Sheba Medical Center","Tel Litwinsky","52621",{"type":70,"coordinates":128},[129,130],34.84588,32.05096,{"lat":130,"lon":129},{"type":133,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100528941","phase-1-study-of-gs-0201-alone-and-in-combination-in-participants-with-advanced-solid-tumors-100528941",false,"NCT06167317","Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors","A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 as Monotherapy and in Combination in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n* Able to understand and give written informed consent.\n* Assigned female or male at birth, 18 years of age or older, and meet the age of majority\u002Fadulthood per local regulations.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria by investigator assessment.\n* Organ function requirements:\n\n  * Adequate hematologic function\n  * Adequate hepatic function\n  * Creatinine clearance\n  * Coagulation\n* Tissue requirement:\n\n  * Parts A, B, C, and D:\n\n    * Pre-treatment tumor tissue is required.\n  * Parts A and C backfill biopsy cohorts:\n\n    * Individuals must agree to fresh pre- and on-treatment biopsies.\n* Individuals assigned male at birth and individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception\n* Willing and able to comply with the requirements and restrictions in this protocol\n* Part A (GS-0201 Monotherapy Dose Escalation) Inclusion Criteria:\n\n  * Histologically\u002Fcytologically confirmed progressive\u002Fadvanced solid tumors with selected molecular lesions.\n  * Individuals must have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy\n* Part B (Dose Expansion) Inclusion Criteria:\n\n  * Disease documented as:\n  * Cohort B1:\n\n    * Histologically or cytologically confirmed progressive\u002Fadvanced selected solid tumor diagnoses harboring defined molecular lesions\n    * Participants may potentially be required to forgo treatment with approved agent(s) to be able to participate in the study\n  * Cohort B2:\n\n    * Histologically or cytologically confirmed progressive\u002Fadvanced solid tumor diagnoses harboring defined molecular lesions not included in Cohort B1\n* Part C (Dose Escalation) Inclusion Criteria:\n\n  * Histologically or cytologically confirmed unresectable locally advanced\u002Fmetastatic selected solid tumors\n* Part D (Dose Expansion) Inclusion Criteria:\n\n  * Disease documented as:\n  * Cohort D1:\n\n    * Histologically or cytologically confirmed unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC)\n  * Cohort D2:\n\n    * Recurrent\u002Fpersistent endometrial cancer\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Known hypersensitivity to any of the study drugs, its metabolites, or formulation excipients\n* Requirement for ongoing therapy with or use of any prohibited medications described in the protocol\n* Individuals with myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with findings suggestive of MDS\u002FAML\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of GS-0201\n* The therapies listed below within the specified timeframe:\n\n  * Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal\u002Fbiliary stent, biopsy) \\\u003C 4 weeks prior to planned Cycle 1 Day 1\n  * Immunotherapy or biologic therapy \\\u003C 21 days prior to planned Cycle 1 Day 1\n  * Chemotherapy \\\u003C 14 days prior to planned Cycle 1 Day 1, or \\\u003C 42 days for mitomycin or nitrosoureas\n  * Targeted small molecule therapy \\\u003C 14 days prior to planned Cycle 1 Day 1\n  * Receipt of experimental therapy within 21 days or 5 experimental treatment half-lives (whichever is longer) prior to planned Cycle 1 Day 1\n  * Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started \\\u003C 14 days prior to planned Cycle 1 Day 1 are not permitted. Hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started ≥ 14 days prior to planned Cycle 1 Day 1\n  * Radiotherapy within 2 weeks prior to planned Cycle 1 Day 1 and the radiation is not administered to a target lesion\n  * Any prior allogeneic tissue\u002Fsolid organ transplantation, including allogeneic hematopoietic stem cell transplantation. Individuals with a history of autologous hematopoietic stem cell transplantation are also excluded\n* Have not recovered (ie, Grade 1 or lower) from AEs due to a previously administered agent\n* Prior treatment with approved or experimental prohibited agents as detailed in the protocol.\n* Diagnosis of immunodeficiency, either primary or acquired, or requires systemic corticosteroids (\\> 10 mg of prednisone daily, or equivalent). However, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted\n* Have an active second malignancy\n* Have known active central nervous system (CNS) metastases\n* Individuals with carcinomatous meningitis or primary CNS tumors are excluded regardless of clinical stability\n* Meet any of the following criteria for cardiac disease:\n\n  * Myocardial infarction or unstable angina pectoris within 6 months of enrollment\n  * History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication)\n  * QT interval \\> 470 msec\n  * New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction less than 40%\n* Meet any of the following infectious criteria:\n\n  * Have active serious infection requiring antimicrobials\n  * Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV. In individuals with a history of HBV or HCV, individuals with detectable viral loads will be excluded\n  * Individuals who test positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody are eligible with a negative HBV DNA by quantitative Polymerase chain reaction (PCR)\n  * Individuals who test positive for HCV antibody. Individuals who test positive for HCV antibody are eligible with a negative HCV RNA by quantitative PCR\n  * Individuals who test positive for HIV antibody\n* History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or radiation pneumonitis requiring steroids\n* Symptomatic ascites or pleural effusion\n* Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations\n* Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the individuals participation in the study\n* Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of study drug(s) (inactivated, viral vector vaccines, and messenger RNA (mRNA) vaccines are allowed; seasonal vaccines should be up to date prior to planned Cycle 1 Day 1)\n* Parts C (Dose Escalation) and D (Dose Expansion): Combination Cohorts:\n\n  * Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and individuals with a history of bowel obstruction or gastrointestinal perforation within 6 months prior to planned Cycle 1 Day 1\n  * Individuals who previously received topoisomerase 1 inhibitors or antibody-drug conjugates containing a topoisomerase 1 inhibitor\n  * Known severe intolerance or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous (IV) immunoglobulin preparations; any history of anaphylaxis; history of human anti-human antibody response\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":144,"type":145},278,"ESTIMATED","INTERVENTIONAL",[148],"PHASE1","The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors.\n\nThe primary objectives of this study are to:\n\n* To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors\n* To identify the maximum tolerated dose (MTD) and\u002For the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and\u002For the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors",[151],"Advanced Solid Tumors","2026-05-26",{"date":154,"type":155},"2026-05-28","ACTUAL",{"date":157,"type":155},"2024-01-09",{"date":159,"type":145},"2028-09",{"name":5,"class":6},7]