[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gilead Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":485},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,40,62,86,108,132,156,178,201,224,248,269,290,311,332,356,378,399,422,445,465],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100633528","phase-2-study-of-denikitug-gs-1811-given-alone-or-with-nivolumab-or-with-chemotherapy-in-adults-with-advanced-colorectal-cancer-100633528",false,"NCT07527858","Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer","A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)","Key Inclusion Criteria:\n\nMedical History\u002FPhysical Characteristics\n\n* Histologically or cytologically confirmed unresectable, recurrent, or locally advanced or metastatic microsatellite stable colorectal cancer (MSS CRC) (adenocarcinoma, excluding appendix cancer).\n* Documented MSS or proficient mismatch repair (pMMR) disease by local assessment using a validated polymerase chain reaction (PCR) (microsatellite status) and\u002For immunohistochemistry (IHC) mismatch repair (MMR) assay is required.\n* Has received up to 2 prior lines of systemic therapy for advanced or metastatic CRC, which must have included at least fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapies if indicated; and if applicable: anti-vascular endothelial growth factor (VEGF) therapy, anti epidermal growth factor receptor (EGFR) therapy, encorafenib or adagrasib\u002Fsotorasib.\n* Documented progressive disease (PD) by computed tomography (CT) or magnetic resonance imaging (MRI) during or after the most recent therapy per RECIST Version 1.1 criteria by investigator assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n\nLaboratory Assessments\n\n* Have adequate organ function.\n\nKey Exclusion Criteria with:\n\nMedical Conditions\u002FHistory:\n\n* Significant cardiovascular disease.\n* History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease or current pneumonitis\u002F interstitial lung disease.\n* History of gastrointestinal (GI) perforation, permanent ileostomy, abdominal abscess or fistula within 6 months, active or uncontrolled GI bleeding within 4 weeks, or any condition associated with significant risk of bleeding or perforation (eg, untreated varices, tumor erosion, recent GI surgery).\n\nPrior\u002FConcurrent Therapy or Clinical Study Experience\n\nPrior treatment with:\n\n* Trifluridine-tipiracil, regorafenib, or fruquitinib.\n* Any immuno-oncology therapy.\n* Anticancer biologic agent within 4 weeks prior to randomization or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to randomization and have not recovered (ie, Grade 2 or less) from AEs from prior anticancer therapy at the time of randomization. Individuals in observational studies are eligible.\n* Allogeneic tissue\u002Fsolid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},170,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based Combinations in participants with advanced microsatellite stable (MSS) colorectal cancer (CRC).\n\nThe primary objective of this study is to assess the effect of DEN as monotherapy and in combination with nivolumab (NIVO) or trifluridine-tipiracil (FTD-TPI) and bevacizumab (BVZ) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1).",[26],"Advanced Microsatellite Stable Colorectal Cancer","RECRUITING","2026-06-30",{"date":30,"type":31},"2026-07-01","ACTUAL",{"date":33,"type":31},"2026-05-19",{"date":35,"type":20},"2028-12",{"name":37,"class":38},"Gilead Sciences","INDUSTRY",8,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100629369","implementation-study-of-lenacapavir-pre-exposure-prophylaxis-for-hiv-prevention-100629369","NCT07473778","Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention","Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)","PROPEL","Key Inclusion Criteria:\n\n* Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures;\n* Willing and able to comply with all study requirements;\n* Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine\u002Ftenofovir disoproxil fumarate (coformulated; Truvada®; F\u002FTDF) or emtricitabine\u002Ftenofovir alafenamide (coformulated; Descovy®; F\u002FTAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive;\n* Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved\u002Fcleared test for diagnosis of acute or primary HIV-1 infection;\n* After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:\n\n  1. Selects LEN PrEP as their chosen PrEP method; OR,\n  2. Selects a different PrEP method or chooses not to start or continue PrEP.\n\nKey Exclusion Criteria:\n\n* Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and\u002For Center for Disease and Control (CDC) guidance.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":49,"type":20},3000,"OBSERVATIONAL","The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.\n\nThe primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.",[53],"HIV Infections","2026-06-26",{"date":28,"type":31},{"date":57,"type":31},"2026-03-17",{"date":59,"type":20},"2029-04",{"name":37,"class":38},28,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100577710","phase-3-study-of-sacituzumab-govitecan-versus-standard-of-care-in-participants-with-previously-treated-extensive-stage-small-cell-lung-cancer-100577710","NCT06801834","Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer","A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","EVOKE-SCLC-04","Key Inclusion Criteria:\n\n* Histologically confirmed diagnosis of SCLC.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.\n* Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC.\n* Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days from last dose of platinum treatment.\n* If the investigator believes a participant may benefit from platinum rechallenge it can be considered per investigator discretion and local SOC; however, participants with platinum rechallenge may not participate in the study.\n* If the investigator believes a participant may benefit from tarlatamab treatment, it can be considered per investigator discretion and local SOC and such participants may participate in the study following tarlatamab treatment.\n\nNote: at least 85% of participants included in the study must be pretreated with anti-PD-\\[L\\]1 therapy.\n\nRefer to protocol for country-specific requirements for participants in China.\n\nKey Exclusion Criteria:\n\n* Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) \\\u003C 30 days (independent of the immunotherapy maintenance).\n* Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. Received lurbinectedin after progression on or after platinum-based chemotherapy.\n* Have carcinomatous meningitis and\u002For non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks (independent from completion of definitive treatment) prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg\u002Fday of prednisone or its equivalent. Participants with untreated, clinically stable brain metastases will be allowed if they are asymptomatic and the investigator determines there is no immediate CNS-specific treatment required, there is no surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer lesions.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":71,"type":20},695,[73],"PHASE3","The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC).\n\nThe primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).",[76],"Extensive Stage Small Cell Lung Cancer (ES-SCLC)","2026-06-23",{"date":79,"type":31},"2026-06-24",{"date":81,"type":31},"2025-04-04",{"date":83,"type":20},"2029-10",{"name":37,"class":38},218,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100638825","phase-1-study-of-gs-2426-in-participants-with-advanced-solid-tumors-100638825","NCT07601243","Study of GS-2426 in Participants With Advanced Solid Tumors","A Phase 1, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Tolerability of GS-2426 in Participants With Advanced MTAP-Deleted Solid Tumors","Key Inclusion Criteria:\n\n* Participants 18 years of age or older (≥ 19 years old for participants in South Korea).\n* Histologically or cytologically confirmed advanced malignant solid tumors, who have progressed on, are intolerant to or are ineligible for standard therapy, or have no standard treatment options.\n* Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient.\n* Adequate organ function\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* All participants must provide a pretreatment tumor tissue sample.\n\nKey Exclusion Criteria:\n\n* Participants with plans to breastfeed during the study period or within 7 days following the last dose of study intervention.\n* Have not recovered (ie, returned to Grade 1 or baseline) from clinically significant adverse events (AEs) due to a previously administered agent or a previous intervention as assessed by the investigator.\n* Active second malignancy. Individuals with a history of malignancy who have been completely treated with no evidence of active cancer for 5 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence may be enrolled.\n* Requirement for ongoing therapy with any prohibited medications .\n* Prior therapy with a protein arginine methyltransferase 5 (PRMT5) inhibitor or methionine adenosine transferase 2a (MAT2A) inhibitor.\n* Have serious infection requiring antibiotics within 14 days prior to the first dose.\n* Uncontrolled concurrent diseases\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":94,"type":20},174,[96],"PHASE1","The goal of this clinical study is to learn more about the study drug GS-2426, and how safe and tolerable it is in participants with advanced methylthioadenosine phosphorylase (MTAP)-deleted solid tumors.\n\nThe primary objective of this study is to evaluate the safety and tolerability of GS-2426 in participants with MTAP-deleted advanced solid tumors and to determine the maximum tolerated dose (MTD)\u002Fmaximum administered dose (MAD) and the recommended phase II dose (RP2D).",[99],"Advanced Solid Tumors","2026-06-19",{"date":79,"type":31},{"date":103,"type":31},"2026-06-02",{"date":105,"type":20},"2029-01",{"name":37,"class":38},2,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100520058","phase-3-seladelpar-in-subjects-with-primary-biliary-cholangitis-pbc-and-compensated-cirrhosis-100520058","NCT06051617","Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis","AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis","AFFIRM","Inclusion Criteria:\n\nIndividuals must meet the following criteria to be eligible for study participation:\n\n1. Must be at least 18 years old.\n2. Must have a confirmed prior diagnosis of PBC\n3. Evidence of cirrhosis\n4. CP Score A or B\n5. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose\n6. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)\n\nExclusion Criteria:\n\nIndividuals must not meet any of the following criteria to be eligible for study participation:\n\n1. Prior exposure to seladelpar\n2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study\n3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.\n4. Decompensated cirrhosis\n5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI\n6. Hospitalization for liver-related complication within 12 weeks of Screening\n7. Laboratory parameters at Screening:\n\n   1. Alkaline phosphatase (ALP) \\\u003C 1.5× Upper limit of normal (ULN) or ≥ 10×ULN\n   2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN\n   3. Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN\n   4. Platelet count ≤50×10\\^3\u002FµL\n   5. Albumin ≤2.8 g\u002FdL\n   6. Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m\\^2\n   7. MELD score \\>12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.\n   8. Serum alpha-fetoprotein (AFP) \\>20 ng\u002FmL\n   9. INR \\>1.7\n8. CP-C cirrhosis\n9. History or presence of other concomitant liver diseases",{"count":117,"type":20},318,[73],"To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.",[121],"Primary Biliary Cholangitis",[123,124],"Primary Biliary Cholangitis (PBC)","PBC",{"date":77,"type":31},{"date":127,"type":31},"2023-09-07",{"date":129,"type":20},"2030-08",{"name":37,"class":38},203,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":16,"minAge":17,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100559344","phase-1-study-of-gs-4571-in-healthy-participants-nondiabetic-obese-participants-and-nonobese-participants-with-type-2-diabetes-mellitus-t2dm-100559344","NCT06562907","Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)","A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Ascending Oral Doses of GS-4571 in Healthy Participants, Multiple Ascending Oral Doses of GS-4571 in Nondiabetic Obese Participants and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM), and to Evaluate the Effect of Food and an Acid-Reducing Agent on Pharmacokinetics of GS-4571","Key Inclusion Criteria:\n\n* Individuals must be glucagon-like peptide-1 receptor agonist (GLP-1RA) naïve OR last dose was at least 6 months prior to screening.\n* Part A (SAD) and Part B (Food\u002FPPI Effect): eligible individuals in Cohorts 1-4, (optional cohort 5) and 6 will include healthy individuals with BMI of ≥ 19 and \\\u003C 30 kg\u002Fm\\^2, and no significant medical history.\n\nIndividuals will also be in good general health as determined by the investigator at the screening evaluation performed no more than 28 days prior to the scheduled first dose.\n\n* Part C (MAD in nondiabetic obese individuals): Eligible individuals in Cohorts 7-9 and (optional cohort 10) will be individuals with obesity with BMI ≥ 30 kg\u002Fm\\^2 and \\\u003C 45 kg\u002Fm\\^2 with a total body weight \\> 50 kg, and nondiabetic (HbA1c \\\u003C 6.5%). Eligible individuals will also be individuals with stable body weight (\\\u003C 5% change) for 90 days prior to screening visit based on individual report.\n* Part D (multiple doses in non-obese T2DM): eligible individuals in Cohort 11 will be individuals with T2DM HbA1c ≥ 7.0% and ≤ 10.5% with BMI of ≥ 19 and \\\u003C 30 kg\u002Fm\\^2 and treated with diet and\u002For exercise, and\u002For metformin monotherapy.\n\nKey Exclusion Criteria:\n\n* Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with individual treatment, assessment, or compliance with the protocol. This would include acute pancreatitis, or history of pancreatitis, acute gallbladder disease, and renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes \\[with the exception of T2DM for individuals included in Part D only\\]), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.\n* Current symptoms of diabetic retinopathy or examination indicating diabetic retinopathy within one year of screening.\n* Any electrolyte disturbances identified at screening considered to be clinically significant in the opinion of the investigator (eg, hypokalemia, hypocalcemia, or hypomagnesemia).\n* Any condition that could lead to electrolyte disturbances (eg, eating disorder) in the opinion of the investigator.\n* History of syncope, palpitations, or unexplained dizziness.\n* Active, or history of, significant cardiac disease or conduction abnormality\n* History of implanted defibrillator or pacemaker.\n* Have been treated with the following within 6 months prior to screening or is expected to receive these agents during the study: GLP-1RAs, systemic steroids, immunosuppressant therapies, or chemotherapeutic agents (eg, corticosteroids, immunoglobulins, other immune or cytokine-based therapies).\n* Previously stopped use of GLP-1RAs secondary to severe side effects including nausea, constipation, diarrhea, or emesis.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"55 Years",{"count":142,"type":20},134,[96],"The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM).\n\nThe primary objectives of this study are:\n\n* To characterize the pharmacokinetics (PK) of GS-4571 following single and multiple ascending oral doses of GS-4571.\n* To evaluate the effect of concomitant food intake and (if conducted) a representative acid-reducing agent (proton pump inhibitor (PPI), omeprazole) on the PK of GS-4571.\n* To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571.",[146],"Weight Management","2026-06-18",{"date":149,"type":31},"2026-06-22",{"date":151,"type":31},"2024-08-28",{"date":153,"type":20},"2026-11",{"name":37,"class":38},3,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100602806","phase-1-study-of-gs-5319-in-adults-with-solid-tumors-100602806","NCT07128303","Study of GS-5319 in Adults With Solid Tumors","A Phase 1 Study to Evaluate the Safety and Tolerability of GS-5319 in Adults With MTAP-deleted Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Participants diagnosed with histologically or cytologically confirmed solid tumor types who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy in the advanced setting (locally-advanced or metastatic).\n* Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient. Deoxyribonucleic acid (DNA) sequencing may be assessed locally such as by local next-generation sequencing (NGS) or by central laboratory assay when available.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n* Adequate organ function\n* Age ≥ 18yrs old ( ≥ 19 years old for patients in South Korea)\n* Participants must meet the following tissue requirements:\n\n  1. Part A and B: pretreatment tumor tissue is required\n\nKey Exclusion Criteria:\n\n* Active second malignancy. Participants with a history of malignancy who have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence may be enrolled.\n* Positive serum pregnancy test or participant who is breastfeeding.\n* Requirement for ongoing therapy with any prohibited medications.\n* Have not recovered (ie, returned to Grade 1 or baseline) from adverse events (AEs) due to a previously administered agent.\n* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.\n* Ascites or pleural effusion that is symptomatic and\u002For requiring medical intervention.\n* Active human immunodeficiency virus (HIV)\u002Fhepatitis B virus (HBV)\u002Fhepatitis C virus (HCV) infection\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":164,"type":20},178,[96],"The goal of this clinical study is to learn more about the study drug, GS-5319, its dosing, safety and tolerability in adults with solid tumors, where the participants show a specific gene alteration in the tumor. The gene helps produce methylthioadenosine phosphorylase (MTAP) enzyme. MTAP enzyme helps in normal growth of cells.\n\nThe primary objectives of the study are to assess the safety and tolerability of GS-5319 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors and to identify the maximum tolerated dose (MTD)\u002Fmaximum administered dose (MAD) and\u002For the recommended dose for expansion (RDE).",[168],"Advanced Solid Tumor","2026-06-15",{"date":171,"type":31},"2026-06-17",{"date":173,"type":31},"2025-08-28",{"date":175,"type":20},"2028-05",{"name":37,"class":38},10,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":139,"sex":16,"minAge":17,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100600338","phase-1-study-of-gs-4321-in-healthy-participants-and-participants-with-chronic-hepatitis-delta-virus-100600338","NCT07096193","Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus","Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta","Key Inclusion Criteria:\n\nPart A:\n\n* Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.\n* Have a body mass index (BMI) of ≤ 30.0 kg\u002Fm2 at screening and at admission.\n\nPart B:\n\n* Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.\n* Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history.\n* Must be receiving a commercially available entecavir, TAF, or TDF for the treatment of hepatitis B virus (HBV) infection at or prior to enrollment. Coformulation as part of a fixed-dose combination for the treatment of HIV is permitted.\n* Non-cirrhotic or compensated cirrhosis.\n* Hepatitis delta virus ribonucleic acid (HDV RNA ) \\> 500 IU\u002FmL at screening.\n* Alanine aminotransferase (ALT) level \\> 1 × Upper limit of normal (ULN), but \\\u003C 10 × ULN at screening.\n\nKey Exclusion Criteria:\n\nPart A:\n\n* Positive serum or urine pregnancy test.\n* Participants with plans to breastfeed during the study period.\n\nPart B:\n\n* Positive serum or urine pregnancy test.\n* Participants with plans to breastfeed during the study period.\n* Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV.\n* Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","69 Years",{"count":187,"type":20},200,[96,23],"The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants. The study will then learn about the safety and effectiveness of GS-4321 in participants with chronic hepatitis delta (CHD).\n\nThe primary objective of Phase 1 of this study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of the escalating single doses of GS-4321 administered in healthy participants.\n\nThe primary objective of Phase 2 of this study is to evaluate the efficacy and safety of the multiple escalating doses of GS-4321 in participants with CHD.",[191],"Chronic Hepatitis Delta","2026-06-09",{"date":194,"type":31},"2026-06-11",{"date":196,"type":31},"2025-07-31",{"date":198,"type":20},"2030-01",{"name":37,"class":38},19,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":208,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},"100541989","phase-4-a-study-to-provide-continued-access-to-study-drug-to-children-and-adolescents-who-have-completed-clinical-studies-involving-gilead-hiv-treatments-100541989","NCT06337032","A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments","An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments","Key Inclusion Criteria:\n\n* Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.\n\nKey Exclusion Criteria:\n\n* Individuals planning to switch to B\u002FF\u002FTAF on Day 1 with plasma HIV RNA ≥ 50 copies\u002FmL during the last parent study visit prior to screening\u002FDay 1 visit.\n\n  * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies\u002FmL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL).\n* Individuals planning to switch to B\u002FF\u002FTAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B\u002FF\u002FTAF prior to treatment switch.\n* For those on B\u002FF\u002FTAF or planning to switch to B\u002FF\u002FTAF: previous treatment discontinuation of any component of B\u002FF\u002FTAF due to toxicity or intolerance.\n* For those planning to switch to B\u002FF\u002FTAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.\n* Ongoing treatment with or prior use of any prohibited medications.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","1 Month",{"count":210,"type":20},350,[212],"PHASE4","The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.\n\nThe primary objectives of this study are as follows:\n\n* To provide continued access to the study drug received in the parent protocol or switch to bictegravir\u002Femtricitabine\u002Ftenofovir (B\u002FF\u002FTAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.\n* To evaluate the safety of the study drug(s) in participants with HIV-1.",[215],"HIV-1-infection",{"date":217,"type":31},"2026-06-10",{"date":219,"type":31},"2024-08-27",{"date":221,"type":20},"2034-03",{"name":37,"class":38},15,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":210},"100487941","phase-3-study-of-sacituzumab-govitecan-hziy-and-pembrolizumab-versus-treatment-of-physicians-choice-in-patients-with-triple-negative-breast-cancer-who-have-residual-invasive-disease-after-surgery-and-neoadjuvant-therapy-ascent-05aft-65-optimice-rdgbg-119nsabp-b-63-100487941","NCT05633654","Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05\u002FAFT-65 OptimICE-RD\u002FGBG 119\u002FNSABP B-63)","A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy","Key Inclusion Criteria:\n\n* Age \\> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:\n\n  * TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO\u002FCAP) guidelines (immunohistochemistry (IHC) and\u002For in situ hybridization (ISH)).\n* Adequate excision and surgical removal of all clinically evident of disease in the breast and\u002For lymph nodes and have adequately recovered from surgery.\n* Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Individuals must have received appropriate radiotherapy aligned with local\u002Finstitutional practice and have recovered prior to starting study treatment.\n* Adequate organ function.\n\nKey Exclusion Criteria:\n\n* Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.\n* Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for \\> 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.\n* Evidence of recurrent disease following preoperative therapy and surgery.\n* Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.\n* Individuals with germline breast cancer gene (BRCA) mutations.\n* Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of \\\u003C 50%\n* Active serious infections requiring anti-microbial therapy.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":232,"type":20},1514,[73],"The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.",[236],"Triple Negative Breast Cancer",[238,239,240,241],"AFT-65","GBG 119","NSABP B-63","OptimICE-RD",{"date":217,"type":31},{"date":244,"type":31},"2022-12-12",{"date":246,"type":20},"2031-08",{"name":37,"class":38},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":260,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":4},"100642421","phase-2-a-study-of-gs-3242-in-combination-with-lenacapavir-versus-biktarvy-in-virologically-suppressed-people-with-hiv-1-100642421","NCT07645287","A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1","A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide) in Virologically Suppressed People With HIV-1","Key Inclusion Criteria:\n\n* Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \\\u003C 50 copies\u002FmL for ≥ 6 months before screening.\n* Plasma HIV-1 RNA levels \\\u003C 50 copies\u002FmL at screening.\n* Receiving bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (coformulated; Biktarvy®) (B\u002FF\u002FTAF) for ≥ 6 months prior to screening.\n* No documented resistance to GS-3242 (integrase mutation Q148H\u002FK\u002FR plus at least 2 of the following integrase mutations: L74I\u002FM, T97A, E138A\u002FK\u002FT, or G140A\u002FC\u002FS).\n\nKey Exclusion Criteria:\n\n* Prior use of, or exposure to GS-3242 or LEN.\n* History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.\n* Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":256,"type":20},175,[23],"The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (B\u002FF\u002FTAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B\u002FF\u002FTAF in Groups 4 and 3 at Week 26.\n\nThe primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B\u002FF\u002FTAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B\u002FF\u002FTAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.",[215],"NOT_YET_RECRUITING","2026-06-08",{"date":263,"type":31},"2026-06-12",{"date":265,"type":20},"2026-06",{"date":267,"type":20},"2033-04",{"name":37,"class":38},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},"100585450","phase-1-study-of-gs-0151-in-participants-with-rheumatoid-arthritis-100585450","NCT06902519","Study of GS-0151 in Participants With Rheumatoid Arthritis","A Phase 1b, Randomized, Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of GS-0151 in Adult Participants With Rheumatoid Arthritis","Key Inclusion Criteria:\n\nMedical History\u002FPhysical Characteristics; All Cohorts:\n\n* Individuals must not be on a biologic disease-modifying antirheumatic drug (b\u002FtsDMARD) on Day 1 and must have discontinued all b\u002FtsDMARDs (including biosimilars and generics) at least 4 weeks prior to Day 1 with the exception of B cell-depleting agents (eg, rituximab), which must be discontinued for at least 6 months prior to Day 1.\n* Ongoing treatment with at least 1 but no more than 2 protocol-permitted conventional synthetic disease-modifying antirheumatic drug (csDMARDs) for at least 12 weeks, at a stable dose for at least 6 weeks prior to Day 1 and remain stable throughout the treatment period:\n\n  1. Use of oral, intramuscular (IM), or subcutaneous(ly) (SC) methotrexate 7.5 to 25 mg\u002Fweek. Individuals on methotrexate must be receiving folic or folinic acid supplementation at a stable dose.\n  2. Oral hydroxychloroquine ≤ 400 mg\u002Fday or chloroquine ≤ 250 mg\u002Fday.\n  3. Oral sulfasalazine 1 to 3 g\u002Fday.\n  4. Oral leflunomide 10 to 20 mg\u002Fday.\n* Use of oral corticosteroids of no more than 10 mg prednisone or equivalent per day is allowed if the dose is stable for at least 14 days prior to Day 1. Inhaled corticosteroids for stable medical conditions are allowed but must have been at a stable dose for at least\n\n  1 week prior to the first dose of study drug. Occasional topical corticosteroids are permitted.\n* Where nonsteroidal anti-inflammatory drug (NSAIDs) or acetaminophen are used, the dose must be stable for at least 1 week prior to Day 1\n* Individuals must have discontinued all high-potency opiates at least 1 week prior to Day 1.\n\nCohort 3 Only:\n\n* Individuals must meet all of the following cohort-specific inclusion criteria, in addition to meeting the inclusion criteria for all individuals , to be eligible for participation in Part B:\n\nModerately to severely active RA defined by the following:\n\nScreening and Day 1:\n\n1. 6 or more tender joints on the tender joint count based on 68 joints (TJC68), AND.\n2. 6 or more swollen joints on the swollen joint count based on 66 joints (SJC66). The distal interphalangeal joints should be evaluated but not included in the total count to determine eligibility.\n\n   Screening Only\n3. Have a hsCRP ≥ ULN\n\n   * Inadequate response or intolerance to at least 1 but no more than 3 b\u002FtsDMARDs with no more than 2 mechanisms of action. A lack of response is defined as documented continued or recurrent disease activity after at least 12 weeks of treatment of RA. Intolerance is defined as any documented adverse effect associated with a b\u002FtsDMARD used according to its respective label.\n\nLaboratory Assessments:\n\nCohort 3 Only:\n\n* Anti-cyclic citrullinated peptide antibody (Anti-CCP) positive and\u002For rheumatoid factor (RF) positive\n\nKey Exclusion Criteria:\n\nMedical Conditions; All Cohorts:\n\n* Have a diagnosis of any generalized musculoskeletal disorder that would interfere with study procedures or assessments per the discretion of the investigator.\n* History of opportunistic infection or immunodeficiency syndrome that would put the individual at risk, as per investigator's judgment.\n* Active infection that is clinically significant, per investigator's judgment, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 60 days of screening; or any infection requiring oral anti-infective therapy within 30 days of screening.\n* History of or current moderate to severe congestive heart failure (New York Heart Association class III or IV), or within the last 6 months prior to screening.\n* History of lymphoproliferative disease or possible current lymphoproliferative disease.\n* History of organ or bone marrow transplant.\n* Have a history of major surgery (requiring regional block or general anesthesia) within the last 12 weeks prior to screening or planned major surgery during the study.\n* History of an infected joint prosthesis or other implanted device with the prosthesis or device still in situ.\n* Clinically significant ECG abnormalities at screening, including electrocardiographic interval between the beginning of the Q wave and termination of the T wave, representing the time for both ventricular depolarization and repolarization to occur (QT) interval corrected for heart rate using the Fridericia formula (QTcF) \\> 450 msec, or hypokalemia if recurrent or persistent \\\u003C 3.0 mmol\u002FL, or family history of long QT syndrome\n\nPrior\u002FConcurrent Therapy or Clinical Study Experience:\n\n* Administration of a live attenuated vaccine 4 weeks prior to Day 1 or planned throughout the study.\n* Participation in any investigational drug\u002Fdevice clinical study within 4 weeks or 5 half-lives prior to screening, whichever is longer. Exposure to investigational biologics should be discussed with the sponsor.\n\nDiagnostic Assessments; All Cohorts:\n\n* Any positive tuberculosis (TB) test using interferon-gamma release assay (IGRA) performed by central laboratory at screening. Tests with inconclusive results may be repeated one time. If an inconclusive test is repeated and is returned with inconclusive results a second time, the individual will be excluded from the study. Individuals with a history of latent or active TB who have been treated with a full course of treatment, as per local guidelines, are eligible without the need for an IGRA at screening. Appropriate documentation of prior treatment is required.\n* Evidence of active hepatitis C virus (HCV) infection. Individuals with positive HCV Ab at screening require reflex testing for HCV ribonucleic acid (RNA). Individuals with positive HCV Ab but negative HCV RNA viral load are eligible per investigator judgment and require HCV viral load monitoring on Day 85 and Day 169.\n* The results of the following laboratory tests performed at the central laboratory at screening meet any of the criteria below (out-of-range laboratory values may be rechecked 1 time, per investigator's judgment, before individual is considered a screen failure):\n\n  1. Hemoglobin \\\u003C 10.0 g\u002FdL (SI: \\\u003C 100 g\u002FL)\n  2. White blood cells \\\u003C 3.0 x 10\\^3 cells\u002Fmm\\^3 (SI: \\\u003C 3.0 x 10\\^9 cells\u002FL)\n  3. Neutrophils \\\u003C 1.5 x 10\\^3 cells\u002Fmm\\^3 (SI: \\\u003C 1.5 x 10\\^9 cells\u002FL)\n  4. Lymphocytes \\\u003C 1.0 x 10\\^3 cells\u002Fmm\\^3 (SI: \\\u003C 1.0 x 10\\^9 cells\u002FL)\n  5. Platelets \\\u003C 100 x 10\\^3 cells\u002Fmm\\^3 (SI: \\\u003C 100 x 10\\^9 cells\u002FL)\n  6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 x upper limit of normal (ULN)\n  7. Total bilirubin level ≥ 2 x ULN unless the individual has been diagnosed with Gilbert's disease and this is clearly documented\n  8. Creatinine clearance \\\u003C 50 mL\u002Fmin (SI: \\\u003C 0.83 mL\u002Fs) based on the Cockcroft-Gault formula\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply","75 Years",{"count":278,"type":20},75,[96],"The goal of this clinical study is to learn more about the study drug GS-0151. The study is done to find how safe, well-tolerated the drug is. This will also assess how the drug is absorbed, modified, distributed and cleared from the body (the pharmacokinetics (PK) of the drug), when given multiple times to participants with rheumatoid arthritis (RA).\n\nThe primary objectives of this study is to assess the safety and tolerability of multiple ascending doses of GS-0151 in participants with RA and to characterize the PK of GS-0151 following multiple doses of GS-0151 in participants with RA.",[282],"Rheumatoid Arthritis",{"date":192,"type":31},{"date":285,"type":31},"2025-05-14",{"date":287,"type":20},"2027-03",{"name":37,"class":38},35,{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":223},"100409902","phase-1-study-of-sacituzumab-govitecan-in-participants-with-advanced-or-metastatic-solid-tumor-and-moderate-liver-impairment-100409902","NCT04617522","Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment","A Phase 1, Open-Label, Dose-Escalation Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan in Subjects With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment","Key Inclusion Criteria for all Individuals:\n\n* Histologically confirmed advanced or metastatic solid tumor that is measurable or nonmeasurable.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g\u002FdL, absolute neutrophil count (ANC) ≥1,500\u002Fmm\\^3, and platelets ≥ 100,000\u002F μL).\n* Creatinine clearance ≥ 30 mL\u002Fmin as assessed by the Cockcroft-Gault equation.\n\nKey Inclusion Criteria for Individuals with Normal Hepatic Function:\n\n* Normal hepatic function (total bilirubin ≤ ULN and aspartate aminotransferase (AST) ≤ 3.0× ULN).\n\nKey Inclusion Criteria for Individuals with Moderate Hepatic Function:\n\n* Moderate hepatic impairment (1.5 × ULN \\\u003C total bilirubin ≤ 3.0 × ULN and any level of AST).\n* For individuals with hepatic encephalopathy, the condition does not, in the Investigator's opinion, interfere with the individual's ability to provide an appropriate informed consent.\n\nKey Exclusion Criteria for all Individuals:\n\n* Have poor venous access.\n* Donated or lost 500mL or more of blood volume (including plasmapheresis) to plans to donate during the study.\n* Have had a prior anticancer biologic agent within 4 weeks prior to Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Day 1 and who have not recovered (i.e., ≤ Grade 1) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.\n* Had prior treatment with irinotecan within 4 weeks prior to Day 1.\n* Have not recovered (i.e., ≤ Grade 1) from AEs due to a previously administered agent.\n* Have an active second malignancy.\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking \\\u003C 20 mg\u002Fday of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have history of cardiac disease.\n* Have active chronic inflammatory bowel disease (ulcerative colitis or Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.\n* Have active serious infection (Contact medical monitor for clarification).\n* High-dose systemic corticosteroids (≥20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Check-In. However, inhaled, intranasal, intra-articular, and topical steroids are allowed.\n* Use of strong inhibitor or inducer of UGT1A1.\n* Have a known history of Gilbert's disease.\n\nKey Exclusion Criteria for Individuals with Normal Hepatic Impairment:\n\n* Must have pre-existing condition interfering with hepatic and\u002For renal function that could interfere with the metabolism and\u002For excretion of the study drug.\n\nKey Exclusion Criteria for Individuals with Moderate Hepatic Impairment:\n\n* Had a significant clinical exacerbation of liver disease symptoms within the 2-week period before administration of study drug (i.e., abdominal pain, nausea, vomiting, anorexia, or fever).\n* Had clinically demonstrable, tense ascites.\n* Had evidence of acute viral hepatitis within 1 month prior to administration of study drug.\n* Have evidence of hepatorenal syndrome.\n* Individuals with transjugular intrahepatic portosystemic shunt (TIPS) placement.\n* Have active Stage 3 or 4 encephalopathy.",{"count":298,"type":20},30,[96],"The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.",[302,303],"Advanced or Metastatic Solid Tumor","Liver Failure","2026-06-01",{"date":103,"type":31},{"date":307,"type":31},"2021-04-06",{"date":309,"type":20},"2026-12",{"name":37,"class":38},{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},"100528941","phase-1-study-of-gs-0201-alone-and-in-combination-in-participants-with-advanced-solid-tumors-100528941","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.",{"count":319,"type":20},278,[96],"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",[99],"2026-05-26",{"date":325,"type":31},"2026-05-28",{"date":327,"type":31},"2024-01-09",{"date":329,"type":20},"2028-09",{"name":37,"class":38},7,{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":21,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":354,"locationsCount":355},"100634986","phase-2-study-of-denikitug-gs-1811-given-alone-or-with-nivolumab-or-chemotherapy-in-adults-with-metastatic-gastric-gastroesophageal-junction-gej-and-esophageal-adenocarcinomas-100634986","NCT07546812","Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas","A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and\u002For Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).\n* Human epidermal growth factor receptor 2 (HER2)-negative status, as determined by local assessment using a validated immunohistochemistry assay, in situ hybridization or other amplification testing.\n* Has had disease progression during or after first line of systemic therapy for advanced or metastatic gastric, GEJ, or EACs, which must have included at least one of the following:\n\n  1. Platinum- and fluoropyrimidine-based chemotherapy.\n  2. Therapy with an anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (anti-PD-L1) monoclonal antibody (patients with PD-L1-positive tumors must have received prior PD-1\u002FPD-L1-based therapy).\n  3. Zolbetuximab or other Claudin-18 (CLDN18).2-targeted therapy, if indicated based on biomarker status.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Have adequate organ function.\n* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.\n\nKey Exclusion Criteria:\n\n* Active or history of autoimmune disease requiring systemic treatment within 2 years, inflammatory bowel disease (IBD) (Crohn's\u002Fulcerative colitis), celiac disease, or noninfectious enteritis\u002Fcolitis. (Physiologic hormone replacement not considered systemic treatment).\n* History or current noninfectious pneumonitis\u002Finterstitial lung disease, including radiation-induced pneumonitis requiring steroids or active\u002Frecurrent pneumonitis of any etiology.\n* Documented microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) disease by local polymerase chain reaction (PCR) (microsatellite status) and\u002For informed consent form (ICH) (mismatch repair (MMR)) assay\n* (For Part 2 only) Has known history of peripheral neuropathy ≥ Grade 2 (per National Cancer Institute(NCI)-Common Tenninology Criteria for Adverse Events (CTCAE) Version 5.0).\n* (For Part 2 only) Known coagulopathy that increases the risk of bleeding, bleeding diatheses. Any other Grade 3 or higher hemorrhage\u002Fbleeding event within 28 days prior to enrollment.\n\nPrior\u002FConcurrent Therapy or Clinical Study Experience\n\n* Prior treatment with DEN or other C-C chemokine receptor 8 (CCR8)-targeted agents.\n* Prior Lonsurf (trifluridine-tipiracil) or paclitaxel (PAC)-based regimens in the first-line setting for advanced\u002Fmetastatic gastroesophageal adenocarcinoma.\n* Any systemic therapy (including investigational) targeting vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) signaling pathways.\n* Anticancer biologic within 4 weeks, orchemotherapy, targeted small molecule, or radiation therapy within 2 weeks prior to enrollment with unresolved adverse events (AE)s (Grade \\>2). (Observational study participants are eligible).\n* Prior allogenic tissue\u002Fsolid organ or stem cell transplantation. (Exception: corneal transplant not requiring systemic immunosuppression is allowed).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":340,"type":20},120,[23],"The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based combinations in in participants with human epidermal growth factor receptor 2 (HER2)-Negative, unresectable, recurrent, and\u002For metastatic, gastroesophageal junction (GEJ), and esophageal adenocarcinomas.\n\nThe primary objective of this study is to assess the effect of DEN as a monotherapy or in combination with nivolumab (NIVO) or ramucirumab (RAM) and paclitaxel (PAC) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version1.1).",[344,345,346,347],"HER2-negative","Gastroesophageal Junction","Esophageal Adenocarcinoma","Gastric Adenocarcinoma","2026-05-14",{"date":350,"type":31},"2026-05-18",{"date":352,"type":20},"2026-05",{"date":198,"type":20},{"name":37,"class":38},1,{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":21,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":377},"100573651","phase-2-evaluation-of-long-acting-lenacapavir-for-the-treatment-of-hiv-1-in-treatment-experienced-adolescents-and-children-100573651","NCT06749054","Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children","A Phase 2, Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Long-Acting Lenacapavir in Combination With an Optimized Background Regimen in Treatment-experienced Adolescents and Children With HIV-1","Key Inclusion Criteria:\n\n* Body weight at screening ≥ 35 kg.\n* On a stable failing antiretroviral (ARV) regimen for \\> 8 weeks before screening and willing to continue the regimen until Day 1.\n* Plasma HIV-1 RNA ≥ 400 copies\u002FmL on at least 2 consecutive occasions spanning at least 6 months, including at screening.\n* Have previously changed their ARV regimen due to treatment failure.\n* ARV treatment options limited due to resistance, tolerability, contraindications, safety, drug access.\n* Able and willing to commit to taking LEN in combination with their OBR.\n* The following laboratory parameters at screening:\n\n  1. Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 using Bedside Schwartz Formula.\n  2. Absolute neutrophil count \\> 0.50 GI\u002FL (\\> 500 cells\u002Fmm\\^3).\n  3. Hemoglobin ≥ 85 g\u002FL (\\> 8.5 g\u002FdL).\n  4. Platelets ≥ 50 GI\u002FL (≥ 50,000\u002Fmm\\^3).\n  5. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal.\n  6. Total bilirubin ≤ 23 μmol\u002FL (≤ 1.5 mg\u002FdL) and direct bilirubin ≤ 7 μmol\u002FL (≤ 0.4 mg\u002FdL).\n\nKey Exclusion Criteria:\n\n* Life expectancy ≤ 1 year.\n* An opportunistic illness requiring treatment within the 30 days prior to screening.\n* Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening.\n* Hepatitis C virus (HCV) antibody positive with detectable HCV RNA at screening.\n* Hepatitis B virus (HBV) surface antigen (HBsAg) positive or HBV core antibody (antibody against hepatitis B core antigen (anti-HBc)) positive; if individual is HBsAg negative and anti-HBc positive but HBV DNA undetectable, individual may be enrolled.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","17 Years",{"count":365,"type":20},12,[23],"The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The study will also see how easy it is for participants to take LEN as injection or an oral pill.\n\nThe primary objectives are to evaluate the pharmacokinetics and safety of LEN in combination with optimized background regimen (OBR) in TE pediatric participants with HIV-1.",[215],"2026-04-22",{"date":371,"type":31},"2026-04-24",{"date":373,"type":31},"2025-03-26",{"date":375,"type":20},"2027-09",{"name":37,"class":38},9,{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":21,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":398},"100557011","phase-1-study-of-gs-2121-given-alone-or-in-combination-in-adults-with-advanced-solid-tumors-100557011","NCT06532565","Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors","A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Participants diagnosed with histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n* Tissue requirements:\n\n  1. Parts A-D: Pre-treatment tumor tissue is required.\n  2. Parts A and C backfill cohorts: Participants must agree to fresh pre- and on-treatment biopsies.\n* Adequate organ function.\n\nKey Exclusion Criteria:\n\n* Positive serum pregnancy test or participant who is breastfeeding.\n* Requirement for ongoing therapy with any prohibited medications.\n* Any anti-cancer therapy, whether investigational or approved within protocol specified time prior to initiation of study including: major surgery (\\\u003C4 weeks), experimental therapy (\\\u003C21 days or \\\u003C5 half-lives whichever is shorter), approved immunotherapy or biologic therapy (\\\u003C28 days), approved chemotherapy (\\\u003C21 days or \\\u003C42 days for mitomycin or nitrosoureas), approved targeted small molecule therapy (\\\u003C14 days or \\\u003C5 half-lives whichever is longer), hormonal therapy or other adjunctive therapy for cancers other than cancer under evaluation in this study (\\\u003C14 days) or radiation therapy (\\\u003C21 days).\n* Any prior allogeneic tissue\u002Fsolid organ transplantation, including allogeneic stem cell transplantation.\n* Have not recovered (ie, returned to Grade 1 or baseline) from AEs due to a previously administered agent.\n* Have known active central nervous system (CNS) metastases and\u002For leptomeningeal disease (LMD).\n* Diagnosis of immunodeficiency, either primary or acquired.\n* History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study treatment.\n* Have an active second malignancy.\n* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.\n* History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).\n* Ascites or pleural effusion that is symptomatic and\u002For requiring medical intervention.\n* Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV.\n* Meet any of the following criteria for cardiac disease: Myocardial infarction or unstable angina pectoris within 6 months of enrollment. 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). Mean QT interval corrected for heart rate using the Fridericia's formula (QTcF) ≥ 470 msec. New York Heart Association Class \\> III congestive heart failure or known left ventricular ejection fraction \\\u003C 40%.\n* Live vaccines within 28 days of initiation of study drug(s).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":386,"type":20},154,[96],"The main goal of this first-in-human (FIH) study is to learn about the safety and dosing of GS-2121 when given alone or in combination with zimberelimab (ZIM) in participants with advanced solid tumors.\n\nThe primary objectives of this study are:\n\n* To assess the safety and tolerability of GS-2121 as monotherapy and GS-2121 in combination with zimberelimab in participants with advanced solid tumors.\n* To identify the maximum tolerated dose (MTD) \u002F maximum administered dose (MAD) and\u002For the recommended phase 2 dose (RP2D) of GS-2121 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.",[99],"2026-04-20",{"date":392,"type":31},"2026-04-21",{"date":394,"type":31},"2024-07-26",{"date":396,"type":20},"2028-06",{"name":37,"class":38},6,{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"100327809","phase-2-study-of-sacituzumab-govitecan-in-participants-with-urothelial-cancer-that-cannot-be-removed-or-has-spread-100327809","NCT03547973","Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread","A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced\u002FMetastatic Urothelial Cancer","TROPHY U-01","Key Inclusion Criteria:\n\nInclusion Criteria for All Cohorts:\n\n* Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).\n* Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.\n* Adequate renal and hepatic function.\n* Adequate hematologic parameters without transfusional support.\n* Individuals must have a 3-month life expectancy.\n\nAdditional Inclusion Criteria for Cohorts 1 to 6:\n\n* Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):\n\n  1. Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;\n  2. Or received neo\u002Fadjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence\u002Fprogression ≤12 months following completion of therapy.\n* Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an Anti-programmed Cell Death Protein 1 (anti-PD-1)\u002F Anti-programmed Death Ligand 1 (PD-L1) therapy.\n* Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1\u002FPD-L1 therapy. Individual may not have received any platinum for treatment of recurrent, metastatic or advanced disease.\n* Cohort 3: Progression or recurrence of UC following a platinum containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy.\n* Cohort 4: Individual has not received any platinum-based chemotherapy in the metastatic or unresectable locally advanced setting. Creatinine clearance of at least 50 mL\u002Fmin calculated by Cockcroft-Gault formula or another validated tool. For individuals receiving cisplatin at 70 mg\u002Fm\\^2 on Day 1 of every 21-day cycle, a creatinine clearance of least 60 mL\u002Fmin calculated by Cockcroft -Gault formula or another validated tool is required. Individuals with creatinine clearance between 50 to 59 mL\u002Fmin are to receive a split dose of cisplatin (35 mg\u002Fm\\^2 Day 1 and Day 8 of every 21-day cycle).\n* Cohorts 4, 5, 6: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.\n* Cohort 5: Individuals received at least 4 cycles and no more than 6 cycles of GEM + cisplatin. No other chemotherapy regimens are allowed in this cohort, with the exception of prior adjuvant or neoadjuvant systemic therapy with curative intent after \\> 12 months from completion of therapy.\n* No evidence of progressive disease following completion of first-line chemotherapy (ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator).\n* Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy.\n* Cohort 6: Cis-ineligible and no prior therapy for metastatic disease or for unresectable locally advanced disease. Checkpoint inhibitor therapy naïve or \\>12 months from completion of adjuvant therapy are permitted.\n* Cohorts 4 and 6: Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Cohorts 1, 2, 3 and 5: Creatinine clearance ≥ 30 mL\u002Fmin as calculated by the Cockcroft-Gault formula unless otherwise specified\n\nAdditional Inclusion Criteria for Cohort 7:\n\n* No prior systemic therapy for locally advanced or metastatic UC. Therapy in the curative setting is allowed provided recurrence is \\> 12 months since the last dose of systemic therapy.\n* Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.\n* Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nKey Exclusion Criteria:\n\nExclusion Criteria for All cohorts:\n\n* Females who are pregnant or lactating.\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has an active second malignancy.\n* Has known active Hepatitis B or Hepatitis C.\n* Has other concurrent medical or psychiatric conditions.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has an active second malignancy.\n\nAdditional Exclusion Criteria for Cohorts 1 to 6:\n\n* For Cohort 5: Alopecia, sensory neuropathy Grade ≤2 is acceptable, or other Grade \\\u003C\\\u003C 2 adverse events not constituting a safety risk based on the investigator's judgment are acceptable.\n* Cohort 3: Has received anti-PD-1\u002FPD-L1 therapy previously.\n* Cohorts 3 to 6: Has an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n* Cohorts 3 to 6: Has received a live vaccine within 30 days prior to the first dose of study drug(s), has history or evidence of interstitial lung disease (ILD) or non-infectious pneumonitis.\n* Cohort 4: Refractory to platinum (i.e., relapsed ≤ 12 months after completion of chemotherapy) in the neoadjuvant\u002Fadjuvant setting.\n* Cohorts 4, 5, and 6: For individuals who received prior CPI, a treatment-free interval \\>12 months between the last treatment administration and the date of recurrence is required.\n\nAdditional Exclusion Criteria for Cohort 7:\n\n* Have had a prior anticancer therapy within 12 months prior to C1D1 or prior radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of investigational product.\n* Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n* Have a Child-Pugh score of B or C.\n* Individuals with uncontrolled diabetes.\n* Have active keratitis or corneal ulcerations.\n* Participants with ongoing sensory or motor neuropathy Grade ≥ 2.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":408,"type":20},827,[23],"The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).",[412],"Metastatic Urothelial Cancer","2026-03-12",{"date":415,"type":31},"2026-03-16",{"date":417,"type":31},"2018-08-13",{"date":419,"type":20},"2030-04",{"name":37,"class":38},135,{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":276,"enrollmentInfo":430,"targetDuration":4,"studyType":21,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":444},"100518394","phase-2-study-of-tilpisertib-fosmecarbil-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100518394","NCT06029972","Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis","A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis","PALEKONA","Key Inclusion Criteria:\n\n* Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75 years of age based on the date of the screening visit.\n* Ulcerative colitis (UC) of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.\n* Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader).\n* Previous treatment history of approved UC therapy with at least one advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action.\n* A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with UC.\n\nKey Exclusion Criteria:\n\n* Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis.\n* Individuals with disease limited to the rectum (ulcerative proctitis) during screening endoscopy.\n* Requirement for ongoing therapy with or prior use of any prohibited medications.\n* Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks.\n\nof randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization.\n\n* History of opportunistic infection.\n* Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":431,"type":20},176,[23],"The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo.\n\nThe primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.",[435],"Ulcerative Colitis","2026-02-10",{"date":438,"type":31},"2026-02-11",{"date":440,"type":31},"2023-12-05",{"date":442,"type":20},"2028-02",{"name":37,"class":38},129,{"id":446,"slug":447,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":21,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":463,"locationsCount":464},"100587325","phase-1-a-study-of-sacituzumab-govitecan-given-at-an-alternative-dose-and-schedule-in-participants-with-advanced-triple-negative-breast-cancer-100587325","NCT06926920","A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer","A Phase 1\u002F2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer","Key Inclusion Criteria:\n\n* Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.\n* Histologically or cytologically locally confirmed TNBC.\n* Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease.\n* Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease.\n* Phase 2: Tumors must be PD-L1 negative, defined as tumor PD-L1 combined positive score (CPS) \\\u003C 10 using the PD-L1 immunohistochemistry (IHC) 22C3 assay. Alternatively, individuals with tumor CPS ≥ 10 will be eligible if they received an anti-PD-(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting or if they cannot be treated with an anti-PD-(L)1 agent. due to a comorbidity.\n* Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status.\n\nDuring Phase 1 safety run-in, individuals must be UGT1A1 wild-type.\n\nAfter Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible.\n\n* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Adequate hematologic counts within 2 weeks prior to enrollment.\n* Adequate hepatic and renal function.\n\nKey Exclusion Criteria:\n\n* Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.\n* Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria will apply.",{"count":453,"type":20},100,[96,23],"The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC).\n\nThe primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).",[236],"2026-01-29",{"date":459,"type":31},"2026-01-30",{"date":461,"type":31},"2025-04-30",{"date":396,"type":20},{"name":37,"class":38},16,{"id":466,"slug":467,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":21,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":483,"locationsCount":484},"100439860","phase-1-study-of-denikitug-gs-1811-given-alone-or-with-zimberelimab-in-adults-with-advanced-solid-tumors-100439860","NCT05007782","Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Denikitug (GS-1811), an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Disease:\n\n  * Part A: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.\n  * Part B: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.\n  * Part C: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or whose disease is indicated for anti- programmed cell death protein 1 or programmed cell death ligand 1 (PD-\\[L\\]1) monoclonal antibody monotherapy.\n  * Part D: Individuals with pathologically confirmed select advanced solid tumors.\n  * Part E: Individuals with pathologically confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatment known to confer clinical benefit.\n  * Part F: Individuals with pathologically-confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatments known to confer clinical benefit; or, for participants who will undergo combination therapy, have disease which is indicated for anti-PD-(L)1 mAb monotherapy.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 for individuals in Parts A, B, and C, and 0 or 1 for individuals in Parts D, E, and F.\n* Adequate organ function.\n* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.\n* Tissue requirement:\n\n  * Parts A, C, D, E and F: Must provide pre-treatment adequate tumor tissue sample prior to enrollment.\n  * Part B and select participants in Parts C and F: Must have fresh pre-treatment and on-treatment biopsies for biomarker analysis.\n\nKey Exclusion Criteria:\n\n* Concurrent anticancer treatment.\n* Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: immunotherapy or biologic therapy (\\\u003C 28 days), chemotherapy (\\\u003C 21 days), targeted small molecule therapy (\\\u003C 14 days), hormonal therapy or other adjunctive therapy (\\\u003C 14 days) or radiotherapy (\\\u003C 21 days).\n* Any prior CCR8 directed therapy.\n* Prior allogeneic tissue\u002Fsolid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.\n* Concurrent active malignancy other than nonmelanoma skin cancer, curatively resected carcinoma in situ, localized prostate cancer, or superficial bladder cancer after undergoing potentially curative therapy with no evidence of disease. Individuals with other previous malignancies are eligible if disease-free for \\> 2 years.\n* History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.\n* History of autoimmune disease or active autoimmune disease requiring systemic treatment within 2 years.\n* History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).\n* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires IV antibiotics.\n* Active hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV), and\u002For human immunodeficiency virus (HIV).\n* Positive serum pregnancy test or breastfeeding female.\n* Live vaccines within 30 days prior to first dose.\n* Significant cardiovascular disease.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":473,"type":20},416,[96],"This is a first-in-human (FIH) study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and\u002For the recommended Phase 2 dose (RP2D) of denikitug (also known as GS-1811) as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.\n\nThis study will be conducted in 6 parts (Parts A, B, and E: monotherapy, Parts C and D: combination therapy, and Part F for both monotherapy and combination therapy) in participants with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or in participants with select solid tumors.",[168],"2025-12-26",{"date":479,"type":31},"2025-12-29",{"date":481,"type":31},"2021-08-18",{"date":35,"type":20},{"name":37,"class":38},26,""]