[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Genentech, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":575},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,43,67,86,106,150,172,194,215,239,262,282,307,330,351,362,388,407,430,448,463,483,512,533,553],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053586","phase-1-a-study-to-evaluate-the-effect-of-gdc-4198-alone-and-in-combination-with-giredestrant-versus-abemaciclib-and-giredestrant-in-participants-with-locally-advanced-or-metastatic-estrogen-receptor-positive-er-human-epidermal-growth-factor-receptor-negative-her2--breast-cancer-100053586",false,"NCT07100106","A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer","A Phase Ib\u002FII Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4\u002F6 Inhibitor","MoonROSE","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic.\n* Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)\u002F College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO\u002FCAP or ESMO guidelines.\n* Disease progression during or after treatment with an approved cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor and approved endocrine therapy (ET) in the locally advanced or metastatic setting.\n* Measurable or non-measurable evaluable, disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy \\>= 6 months.\n\nExclusion Criteria:\n\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines.\n* Have received more than one-line of therapy for locally advanced or metastatic disease.\n* Have received prior chemotherapy for metastatic breast cancer.\n* Treatment with an approved oral ET within 7 days prior to initiation of study drug; treatment with fulvestrant or an approved CDK4\u002F6 inhibitor within 21 days prior to initiation of study drug.\n* Malabsorption condition or other gastrointestinal (GI) conditions\u002Fsurgeries that the investigator assesses may significantly interfere with enteral absorption\n* History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk of metastasis or death.\n* Known allergy or hypersensitivity to any component of the study treatments.","ALL","18 Years",{"count":21,"type":22},285,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.",[29],"Breast Cancer","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2025-10-07",{"date":38,"type":22},"2028-08-31",{"name":40,"class":41},"Genentech, Inc.","INDUSTRY",52,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100627392","phase-2-a-study-to-evaluate-the-efficacy-safety-pharmacodynamics-pd-and-pharmacokinetics-pk-of-selnoflast-in-reducing-vascular-inflammation-in-participants-with-atherosclerosis-at-risk-for-major-adverse-cardiac-events-100627392","NCT07448038","A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac Events","A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Selnoflast in Reducing Vascular Inflammation in Patients With Atherosclerosis at Risk for Major Adverse Cardiac Events","RIVULET","Inclusion Criteria:\n\n* Confirmed evidence of atherosclerosis\n* Left or right carotid TBR ≥ 1.8 or aorta TBR ≥ 2.0 on centrally-assessed 18F-fluorodeoxyglucose-Positron Emission Tomography (18F-FDG-PET) scan\n* Stable treatment of atherosclerosis through the use of SOC medications or revascularization\n* QT interval corrected through use of Fridericia's formula (QTcF) of ≤ 450 milliseconds (ms) in men and ≤ 470 ms in women by a single 12-lead electrocardiogram (ECG) recording\n\nExclusion Criteria:\n\n* Individuals with Class III and IV heart failure\n* Uncontrolled cardiac arrhythmia\n* Uncontrolled hypertension\n* Suspected or known immunocompromised state\n* Planned procedure or surgery during the study and any major surgery within 90 days prior to screening Visit 1\n* History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer\n* Positive test results for hepatitis B (HBV) infection at screening\n* Positive hepatitis C virus (HCV) antibody test at screening\n* Positive human immunodeficiency virus (HIV) test at screening\n* Treatment with any live vaccine within 28 days prior to the first dose of study drug until the end of the study\n* Treatment with other non-live vaccines within 14 days prior to the first dose of study drug until the end of the study","80 Years",{"count":53,"type":22},162,[26],"The main purpose of the study is to evaluate the efficacy of selnoflast compared with placebo in participants with atherosclerosis, at high-risk for major adverse cardiovascular event (MACE), who are currently on standard-of-care (SOC) therapy.",[57],"Atherosclerosis","2026-07-01",{"date":60,"type":34},"2026-07-02",{"date":62,"type":34},"2026-06-05",{"date":64,"type":22},"2028-02-28",{"name":40,"class":41},15,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100609444","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-gdc-0587-as-a-monotherapy-and-in-combination-with-giredestrant-in-participants-with-locally-advanced-or-metastatic-estrogen-receptor-positive-and-human-epidermal-growth-factor-receptor-2-negative-erher2--breast-cancer-100609444","NCT07214662","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+\u002FHER2-) Breast Cancer","A Phase Ia\u002FIb Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Patients With Locally Advanced Or Metastatic ER-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After CDK4\u002F6 Inhibitor Therapy","Inclusion Criteria:\n\n* Agreement to adhere to the contraception requirements\n* For females of childbearing potential ≤60 years of age and males: treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Cycle 1, Day 1 and agreement to continue LHRH agonist therapy for the duration of the study\n* Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic\n* Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)\u002F College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO\u002FCAP or ESMO guidelines\n* Disease progression during or following treatment with an approved CDK 4\u002F6 inhibitor, with or without endocrine therapy, in the locally advanced or metastatic setting\n* Measurable, or non-measurable but evaluable, disease per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Life expectancy ≥6 months\n* Creatinine clearance ≥60 milliliter per minute (mL\u002Fmin) (calculated through use of the Cockcroft-Gault formula)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines\n* Five or more prior lines of systemic therapy in the locally advanced or metastatic setting\n* Treatment with anti-cancer therapies, including investigational therapies, within 28 days or 5 drug elimination half-lives, whichever is shorter, prior to initiation of study drug\n* Treatment with an approved oral endocrine therapy within 7 days prior to initiation of study drug or treatment with fulvestrant or an approved\u002Finvestigational CDK inhibitor within 21 days prior to initiation of study drug\n* History of Grade ≥3 adverse event attributed to prior CDK inhibitor therapy that resulted in permanent discontinuation of prior CDK inhibitor therapy\n* Poor peripheral venous access\n* Malabsorption condition or other gastrointestinal (GI) conditions\u002Fsurgeries that the investigator assesses may significantly interfere with enteral absorption\n* Major surgical procedure within 28 days prior to initiation of study drug\n* Untreated, active CNS metastases\n* Infection requiring systemic (i.e., oral, IV, or intramuscular) antibiotics, chronic infection requiring treatment within 1 year prior to screening, or any evidence of current infection\n* History of malignancy within 3 years prior to screening, except for cancer under investigation in this study\n* Known history of a clinically significant abnormal ECG",{"count":75,"type":22},136,[25],"This is a first-in-human, Phase Ia\u002FIb, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 \\[CDK4\\] inhibitor) as a monotherapy and in combination with giredestrant in participants with locally advanced or metastatic estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+\u002FHER2-) breast cancer who have previously progressed during or after CDK 4\u002F6 inhibitor therapy.",[29],{"date":60,"type":34},{"date":81,"type":34},"2026-01-13",{"date":83,"type":22},"2030-06-01",{"name":40,"class":41},4,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100510525","phase-1-a-study-evaluating-the-safety-pharmacokinetics-and-activity-of-the-combination-of-cevostamab-and-elranatamab-in-participants-with-relapsed-or-refractory-multiple-myeloma-rr-mm-100510525","NCT05927571","A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R\u002FR MM)","An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Diagnosis of R\u002FR MM per IMWG criteria\n* For female participants of childbearing potential: agreement to remain abstinent or use contraception\n* For male participants: agreement to remain abstinent or use a condom\n\nExclusion Criteria:\n\n* Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)\n* Prior treatment with elranatamab\n* Prior allogeneic stem cell transplantation (SCT)\n* Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells\n* Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome\n* Participants with known history of amyloidosis\n* History of autoimmune disease\n* History of confirmed progressive multifocal leukoencephalopathy\n* Peripheral motor polyneuropathy of prespecified grade\n* Known or suspected chronic cytomegalovirus (CMV) and\u002For Epstein-Barr virus (EBV) infection\n* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)\n* Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n* Human immunodeficiency virus (HIV) seropositivity\n* History of central nervous system (CNS) myeloma disease\n* Significant cardiovascular disease",{"count":94,"type":22},120,[25],"The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.",[98],"Relapsed or Refractory Multiple Myeloma",{"date":60,"type":34},{"date":101,"type":34},"2023-08-10",{"date":103,"type":22},"2027-07-31",{"name":40,"class":41},14,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100523522","phase-2-a-study-evaluating-atezolizumab-with-or-without-bevacizumab-in-participants-with-unresectable-hepatocellular-carcinoma-and-child-pugh-b7-and-b8-cirrhosis-100523522","NCT06096779","A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis","A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis","Kirros","General Inclusion Criteria:\n\n* Locally advanced or metastatic and\u002For unresectable HCC with diagnosis confirmed by histology\u002Fcytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants\n* Disease that is not amenable to curative surgical and\u002For locoregional therapies\n* No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and\u002For unresectable HCC\n* Measurable disease (at least one untreated target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days prior to initiation of study treatment\n* Child-pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment\n* Adequate hematologic and end-organ function\n* Life expectancy of at least 12 weeks\n* Female participants of childbearing potential must be willing to avoid pregnancy and egg donation\n* Absolute neutrophil count ≥1.0 x 10\\^9 per liter (\u002FL) (≥1000 per microliter \\[\u002FμL\\]) without granulocyte colony-stimulating factor support\n* Platelet count ≥ 50 × 109\u002FL (50,000\u002FμL) without transfusion\n* Hemoglobin ≥ 80 grams per liter (g\u002FL) (8 grams per deciliter \\[g\u002FdL\\]) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal (ULN)\n* Serum bilirubin ≤ 3 × ULN\n* Creatinine clearance ≥ 50 milliliters per minute (mL\u002Fmin) (calculated using the Cockcroft-gault formula)\n* Serum albumin ≥ 20 g\u002FL (2.0 g\u002FdL) without transfusion in the prior 3 months\n* International normalized ratio (INR) ≤2.3\n\nGeneral Exclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure\n* Treatment with systemic immunostimulatory agents\n* Treatment with systemic immunosuppressive medication\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment\n* Inadequately controlled hypertension\n* Active or history of autoimmune disease or immune deficiency\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Participants who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation\n* Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonal inhibitors) are not excluded\n* Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Prior allogeneic stem cell or solid organ transplantation\n* Actively listed for liver transplantation\n* Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)\n* Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or that are at high risk for bleeding\n* A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study treatment\n* Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment\n* Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months of study treatment\n* History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable in Cohort B\n* Diagnostic paracentesis is allowed. Therapeutic paracentesis: one large volume paracentesis prior to enrollment with diuretic controlled ascites is allowed.\n* Participants with ascites controlled on diuretics are allowed\n* History of spontaneous bacterial peritonitis within last 12 months",{"count":115,"type":22},30,[26],"The purpose of this study is to assess the safety of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-pugh B7 or B8 cirrhosis.",[119],"Hepatocellular Carcinoma",[121,122,123,124,119,125,126,127,128,112,129,130,131,132,133,134,135,136,137,138,139,140],"Cirrhosis","Liver Cancer","Liver Tumor","Child-pugh B","Atezolizumab","Bevacizumab","Immune Checkpoint Inhibitor","Digestive System Neoplasms","ML44719","Liver Disease","Genentech","Immunotherapy","CPB","CPB 7","CPB 8","Tecentriq","Avastin","HCC","Cirrhotic Liver","Fatty Liver","2026-06-28",{"date":143,"type":34},"2026-06-30",{"date":145,"type":34},"2024-07-15",{"date":147,"type":22},"2027-12-30",{"name":40,"class":41},62,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100563701","phase-1-a-study-to-evaluate-safety-pharmacokinetics-and-activity-of-gdc-7035-as-a-single-agent-and-in-combination-in-patients-with-advanced-solid-tumors-100563701","NCT06619587","A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors","A Phase I\u002FII Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation","Inclusion Criteria:\n\n* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation\n* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm\n\nExclusion criteria:\n\n* Malabsorption or other condition that would interfere with enteral absorption\n* Active brain metastases\n* Clinically significant cardiovascular dysfunction or liver disease",{"count":158,"type":22},410,[25],"This is a first-in-human Phase I\u002FII, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.",[162],"Solid Tumor","2026-06-26",{"date":165,"type":34},"2026-06-29",{"date":167,"type":34},"2024-11-14",{"date":169,"type":22},"2028-05-31",{"name":40,"class":41},41,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100518507","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-ro7566802-as-a-single-agent-and-in-combination-with-atezolizumab-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100518507","NCT06031441","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Life expectancy \\>=3 months, in the investigator's judgment\n* Adequate hematologic and end-organ function\n* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care\n* Measurable disease per RECIST v1.1\n* Tumor specimen availability, for certain cohorts\n\nExclusion Criteria:\n\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to Cycle 1 Day 1, with certain exceptions\n* Active hepatitis B or C\n* Active tuberculosis\n* Positive test for human immunodeficiency virus (HIV) infection\n* Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease\n* Prior allogeneic stem cell or organ transplantation\n* Uncontrolled tumor-related pain\n* Significant cardiovascular disease\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":180,"type":22},250,[25],"This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.",[184,185,186],"Locally Advanced Solid Tumors","Recurrent Solid Tumors","Metastatic Solid Tumors",{"date":165,"type":34},{"date":189,"type":34},"2023-11-27",{"date":191,"type":22},"2027-12-31",{"name":40,"class":41},18,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100591354","phase-2-a-study-to-evaluate-the-efficacy-safety-and-pharmacokinetics-pk-of-ro7837195-in-participants-with-moderately-to-severely-active-ulcerative-colitis-uc-100591354","NCT06979336","A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)","A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n* Diagnosis of ulcerative colitis (UC) established at least 3 months\n* Moderately to severely active UC assessed by mMS\n* Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC\n\nExclusion Criteria:\n\n* Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC\n* Diagnosis of Crohn's disease or indeterminate colitis\n* Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)\n* Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and\u002For IL-23",{"count":202,"type":22},224,[26],"The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and\u002For advanced therapies has failed.",[206],"Ulcerative Colitis","2026-06-25",{"date":163,"type":34},{"date":210,"type":34},"2025-09-29",{"date":212,"type":22},"2028-10-31",{"name":40,"class":41},101,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":222,"sex":18,"minAge":19,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},"100619245","phase-1-a-dose-escalation-study-of-ro7875913-in-healthy-participants-100619245","NCT07342114","A Dose-Escalation Study of RO7875913 in Healthy Participants","A Phase I Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of RO7875913 in Healthy Volunteers","Inclusion Criteria:\n\n* Agreement to adhere to the contraception requirements\n* Body weight \\> 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg\u002Fm\\^2)\n\nExclusion Criteria:\n\n* Positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen\n* History of any malignancy\n* Major surgical procedure within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders\n* Known allergy or hypersensitivity to any component of the RO7875913 formulation\n* Treatment with investigational biologic therapy (or blinded comparator) within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug\n* Treatment with investigational non-biologic therapy (or blinded comparator) within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug\n* Treatment with any immunosuppressive medication within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug",true,"65 Years",{"count":225,"type":22},40,[25],"The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of RO7875913 in healthy participants.",[229],"Healthy Volunteers","2026-06-19",{"date":232,"type":34},"2026-06-24",{"date":234,"type":34},"2026-03-11",{"date":236,"type":22},"2026-12-31",{"name":40,"class":41},1,{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":255,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},"100591739","phase-1-a-study-to-evaluate-the-safety-tolerability-cellular-kinetics-pharmacodynamics-and-efficacy-of-p-cd19cd20-allo1-in-participants-with-severe-treatment-refractory-systemic-lupus-erythematosus-sle-100591739","NCT06984341","A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)","A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Patients With Severe, Treatment-refractory Systemic Lupus Erythematosus","Key Inclusion criteria:\n\n18-75 years old\n\nSLE diagnosis per 2019 EULAR\u002FACR classification criteria ≥ 24 weeks\n\nAutoantibody positive and low complement at screening\n\nTreatment refractory: Failed ≥ 2 treatments for at least 3 months\n\nHighly active disease:\n\nSLEDAI-2K ≥ 8 (excluding alopecia, headache, and fever; additional protocol-specified requirements to enhance specificity of findings)\n\nBILAG-2004 cat A in ≥ 1 organ system and\u002For cat B in ≥ 2 organ systems (excluding constitutional, musculoskeletal, and\u002For mucocutaneous organ systems for category B)\n\nPGA score ≥ 1.0 on a 0 to 3 VAS\n\nFor patients with lupus nephritis:\n\nBiopsy-proven Class III or IV (± Class V) active LN per 2018 ISN\u002FRPS criteria within 12 months of screening\n\nModified NIH activity index ≥ 1\u002F24\n\nUPCR ≥ 1g\u002Fg\n\nKey Exclusion criteria:\n\nParticipants who are pregnant, breastfeeding, or intend to become pregnant within the timeframe in which contraception is required\n\nPrior treatment with CAR T-cell therapy, B-cell-targeting T-cell-dependent bispecific antibody, gene therapy product, total body irradiation, allograft organ transplant, or hematopoietic stem cell transplant\n\nSignificant organ impairment (renal, hepatic, cardiac, or pulmonary) or uncontrolled medical disease which, in the investigator's opinion would preclude patient participation or that may require treatment with systemic corticosteroids or immunosuppressants during the study\n\nActive severe or unstable neuropsychiatric disease\n\nProtocol-specified active or chronic infections, recent major episode of infection\n\nHigh-risk medical conditions (e.g. high bleeding risk, history of cancer, recent major surgery, history of HLH\u002FMAS, substance abuse within the previous year)\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply","75 Years",{"count":53,"type":22},[25],"The purpose of this study is to evaluate the safety and tolerability of P-CD19CD20-ALLO1 in participants with highly active, severe, refractory SLE with or without lupus nephritis (LN). This study includes a dose-escalation stage followed by an expansion stage. It will also evaluate the cellular kinetics (CK), pharmacodynamics (PD), and efficacy of P-CD19CD20-ALLO1.",[251],"Systemic Lupus Erythematosus",[253,254],"Lupus Nephritis","CAR-T therapy","NOT_YET_RECRUITING",{"date":232,"type":34},{"date":143,"type":22},{"date":259,"type":22},"2033-11-01",{"name":40,"class":41},2,{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":279,"leadSponsor":281,"locationsCount":238},"100635917","phase-1-a-study-to-evaluate-ro7851624-in-participants-with-relapsedrefractory-multiple-myeloma-rrmm-100635917","NCT07558915","A Study to Evaluate RO7851624 in Participants With Relapsed\u002FRefractory Multiple Myeloma (RRMM)","An Open-Label, Multicenter, Phase Ia\u002Fb Study Evaluating the Safety and Pharmacokinetics of RO7851624 in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 12 weeks.\n* Diagnosis of multiple myeloma per International Myeloma Working Group (IMWG) criteria.\n* Measurable disease.\n\nExclusion Criteria:\n\n* Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) with insufficient washout prior to first dose of study treatment.\n* Autologous stem cell transplant (SCT) with insufficient time prior to first dose of study treatment.\n* Prior allogeneic SCT.\n* Prior solid organ transplantation.",{"count":270,"type":22},160,[25],"This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors \\[PIs\\], immunomodulators \\[IMiDs\\], and anti-cluster of differentiation 38 \\[anti-CD38\\] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.",[274],"Relapsed\u002FRefractory Multiple Myeloma","2026-06-18",{"date":277,"type":34},"2026-06-23",{"date":277,"type":22},{"date":280,"type":22},"2031-10-01",{"name":40,"class":41},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":289,"minAge":19,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":255,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":304,"leadSponsor":306,"locationsCount":4},"100634545","phase-3-a-study-evaluating-adherence-tolerability-and-patient-reported-outcomes-of-giredestrant-in-participants-with-erher2--early-breast-cancer-who-are-intolerant-to-adjuvant-aromatase-inhibitor-therapy-novera-breast-cancer-100634545","NCT07541079","A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+\u002FHER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)","A Phase IIIb, Single-Arm, Open-Label Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes (PRO) of Giredestrant in Patients With ER+\u002FHER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy","Inclusion Criteria:\n\n* Considered appropriate for treatment with endocrine therapy (ET)\n* Histologically confirmed diagnosis of ER+\u002FHER2-, Stage I-III (low-\u002Fmedium-\u002Fhigh-risk) early breast cancer (eBC)\n* Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP), defined as ≥1% of tumor cells stained positive\n* Documented HER2- tumor according to ASCO\u002FCAP\n* Postmenopausal females at the time of signing the Informed Consent Form\n* Documented use of a prior adjuvant aromatase inhibitor (AI) (i.e., anastrozole, exemestane, or letrozole) for a total of ≥6 months\n* Documented use of an adjuvant AI (i.e., anastrozole, exemestane, or letrozole) for the consecutive ≥3 months immediately prior to consent\n* Participant and investigator agree that current symptoms on AI are intolerable and warrant a switch in therapy to attempt sustained treatment\n* Documented Grade 2 or 3 adverse events, per NCI CTCAE v6.0, determined by the investigator to be associated with AI therapy's intolerance\n* Participant and investigator planning the first switch from an AI\n* Has completed the following: (neo)adjuvant chemotherapy (if administered), definitive surgery of primary breast tumor(s) and\u002For axillary lymph nodes dissection (ALND) and\u002For sentinel lymph node biopsy (SLNB) and\u002For radiotherapy\n* Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1\n\nExclusion Criteria:\n\n* Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents\n* Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease\n* Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs)\n* Have active cardiac disease or history of cardiac dysfunction\n* Have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus \\[HBV\\] or hepatitis C virus \\[HCV\\]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis\n* Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment\n* Have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study","FEMALE",{"count":291,"type":22},300,[293],"PHASE3","The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.",[296],"Early Breast Cancer",[298,299,300,301],"Estrogen receptor positive","ER+","Human epidermal growth factor receptor 2 negative","HER2-",{"date":277,"type":34},{"date":143,"type":22},{"date":305,"type":22},"2034-06-30",{"name":40,"class":41},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":314,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100487363","phase-2-a-study-to-optimize-subretinal-surgical-delivery-and-to-evaluate-safety-and-activity-of-opregen-in-participants-with-geographic-atrophy-secondary-to-age-related-macular-degeneration-galette-adaptive-optics-ao-retinal-imaging-substudy-in-association-with-study-gr44251-100487363","NCT05626114","A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251","A Phase IIa, Multicenter, Open-label, Single-Arm Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration","Inclusion Criteria:\n\n* Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care\n* Diagnosis of GA secondary to AMD\n* Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS)\n* Pseudophakic (study eye)\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* History of cognitive impairment or dementia\n* Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the participant at special risk\n\nOcular Exclusion Criteria for Study Eye:\n\n* Any current or history of ocular disease other than GA that may confound assessment of the macula\n* History of retinal detachment\n* History of vitrectomy, glaucoma-filtering surgery, or corneal transplant\n* Uncontrolled glaucoma or advanced glaucoma\n* Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen\n* History of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications\n* Any existing posterior segment device or implant\n\nSubstudy:\n\nInclusion Criteria:\n\n\\- Participants must meet all of the inclusion criteria described in the parent study GR44251 and have the ability to comply with the substudy protocol\n\nExclusion Criteria:\n\n* Participants who meet any exclusion criteria listed in the parent study GR44251\n* Past history of seizures, or epileptic seizures due to any cause except for a single febrile seizure in childhood","50 Years",{"count":316,"type":22},60,[26],"This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated.\n\nThe substudy will evaluate the operational feasibility and scientific interpretability of incorporating AO retinal imaging using the EarlySight Cellularis® Discovery device. Participants who have fulfilled the eligibility requirements for the parent study and meet the substudy's eligibility criteria will have the option to participate in the substudy. The EarlySight Cellularis® Discovery device will be used only as an assessment tool and data obtained from this device will not be used to guide clinical care or influence clinical outcomes for participants.",[320],"Geographic Atrophy",[322],"Geographic Atrophy Secondary to Age-related Macular Degeneration",{"date":277,"type":34},{"date":325,"type":34},"2023-03-23",{"date":327,"type":22},"2031-03-01",{"name":40,"class":41},17,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":350},"100625660","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacodynamics-and-pharmacokinetics-of-ro7823653-in-participants-with-diabetic-macular-edema-dme-100625660","NCT07425522","A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)","A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema","Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and\u002For American Diabetes Association\n* Glycated hemoglobin (HbA1c) \\\u003C= 12%\n* For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) \\>= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters\n\nExclusion Criteria:\n\n* Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required\n* Uncontrolled blood pressure\n* For Parts 1 and 2: Any history of ocular injection\u002Fimplant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF\u002Fanti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant.\n* For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant\n* History of uveitis, vitritis (grade trace or above), and\u002For scleritis in either eye\n* Active intraocular inflammation in either eye\n* Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye",{"count":338,"type":22},93,[25],"The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.",[342],"Diabetic Macular Edema","2026-06-16",{"date":275,"type":34},{"date":346,"type":34},"2026-04-21",{"date":348,"type":22},"2028-11-17",{"name":40,"class":41},10,{"id":352,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":27,"conditions":355,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":359,"leadSponsor":360,"locationsCount":361},"100600639",{"count":21,"type":22},[25,26],[29],"2026-06-12",{"date":343,"type":34},{"date":36,"type":34},{"date":38,"type":22},{"name":40,"class":41},45,{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":369,"minAge":19,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":377,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":387},"100500777","phase-1-a-study-evaluating-the-safety-pharmacokinetics-and-activity-of-ro7656594-in-participants-with-advanced-or-metastatic-prostate-cancer-100500777","NCT05800665","A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer","A Phase 1, Open-Label, Multicenter, Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 in Patients With Advanced or Metastatic Prostate Cancer","Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n2. Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.\n3. Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).\n4. Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen, unless otherwise specified.\n5. For participants with a known pathogenic breast cancer gene 1 (BRCA1) or BRCA2 mutation: prior therapy with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor, or are considered ineligible for treatment with a PARP inhibitor, if such therapy is approved and available.\n\nKey Exclusion Criteria:\n\n1. Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever is longer, not to exceed 28 days) prior to the first study treatment.\n2. Treatment with any investigational agent within 28 days prior to the first study treatment.\n3. Treatment with any previous AR protein degrader.\n4. Untreated central nervous system (CNS) metastases or leptomeningeal disease.\n\nNote: Other protocol specified inclusion\u002Fexclusion criteria may apply.","MALE",{"count":371,"type":22},210,[25],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will also identify recommended doses and regimens for RO7656594 for subsequent studies.",[375,376],"Advanced Prostate Cancer","Metastatic Prostate Cancer",[378],"Castration-resistant","2026-06-11",{"date":381,"type":34},"2026-06-15",{"date":383,"type":34},"2023-05-02",{"date":385,"type":22},"2027-06-30",{"name":40,"class":41},26,{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":289,"minAge":4,"maxAge":4,"enrollmentInfo":394,"targetDuration":396,"studyType":397,"phases":4,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":238},"100188778","the-mycophenolate-pregnancy-registry-100188778","NCT01733082","The Mycophenolate Pregnancy Registry","Inclusion Criteria:\n\n* Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment\n\nExclusion Criteria:\n\n* Pregnancies for which there is paternal exposure only\n* Pregnancies occurring outside the U.S.",{"count":395,"type":22},500,"2 Years","OBSERVATIONAL","The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified.\n\nThis is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.",[400],"Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases",{"date":381,"type":34},{"date":403,"type":34},"2012-11-20",{"date":405,"type":22},"2040-12-31",{"name":40,"class":41},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":18,"minAge":314,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":429},"100427994","phase-4-a-study-assessing-corneal-endothelial-cells-in-participants-with-neovascular-age-related-macular-degeneration-namd-treated-with-the-port-delivery-system-with-ranibizumab-pds-100427994","NCT04853251","A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)","A Phase IV, Multicenter, Open-label Study to Assess Corneal Endothelial Cells in Patients With Neovascular Age-related Macular Degeneration Treated With the Port Delivery System With Ranibizumab (PDS)","Belvedere","Inclusion Criteria\n\nOcular Inclusion Criteria:\n\n* Diagnosis of nAMD prior to screening as determined by the investigator\n* Difference of \\\u003C10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center\n* Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion\n* Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening\n* Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following:\n\n  * Overall decrease in nAMD disease activity detected on historical or screening OCT\n  * Stable or improved best-corrected visual acuity (BCVA)\n* BCVA of 34 letters (approximate 20\u002F200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment\n* All subtypes of nAMD lesions are permissible\n* nAMD lesions at the time of diagnosis must involve the macula\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images\n\nExclusion Criteria\n\nPrior Ocular Treatment\n\nStudy Eye:\n\n* Prior treatment with external-beam radiation therapy or transpupillary thermotherapy\n* Previous treatment with verteporfin injection (PDT) or corticosteroid IVT injection within 2 years of screening\n* Previous laser (except PDT as stated above) used for age related macular degeneration (AMD) treatment\n* History of corneal transplant\n* History of conjunctival surgery in the superotemporal quadrant\n* History of intraocular inflammation following anti-VEGF injection\n\nEither Eye:\n\n* Previous PDS implantation\n* Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment\n* Prior vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)\n* Prior pars plana vitrectomy surgery\n* Previous intraocular device implantation, excluding intraocular lenses\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery\n* Prior participation in a clinical trial involving any intravitreal agents that are not approved at time of screening\n* Intraocular laser therapy, including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening\n* Contact lens wear in either eye within 2 months of screening\n* Any prior penetrating ocular trauma\n* Any prior ocular blunt trauma affecting corneal or retinal health in the opinion of the investigator, or any ocular blunt trauma within 6 months of screening\n* History of corneal transplantation, including partial-thickness corneal grafts\n* Prior treatment with brolucizumab\n* Prior treatment with external-beam radiation therapy or brachytherapy\n* History of hypersensitivity to ranibizumab or any excipients of Susvimo\n\nMacular Neovascularization Lesion (MNV) Characteristics\n\nStudy Eye:\n\n* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area \\[1.27 square millimeters (mm\\^2)\\] in size\n* Subfoveal fibrosis or subfoveal atrophy\n\nEither Eye:\n\n* MNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia\n* MNV masquerading lesions (e.g., cone dystrophy, adult vitelliform dystrophy, pattern dystrophy)\n\nCurrent or Historical Ocular Conditions\n\nStudy Eye:\n\n* Retinal pigment epithelial tear\n* Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment\n* Current vitreous hemorrhage\n* Current or history of retinal detachment\n* Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation\n* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus examination\n* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery\n* Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia\n* Preoperative refractive error that exceeds 5 diopters of hyperopia, for participants who have undergone prior refractive or cataract surgery\n* Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study\n* Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification)\n* Conjunctival pathologies in the superotemporal quadrant\n* History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis\n* Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure\n* Trichiasis\n* Corneal neuropathy\n* Lagophthalmos or incomplete blink\n* Active or history of facial nerve palsy\u002Fparesis\n\nFellow (Non-Study) Eye:\n\n• Concurrent or history of PDS implantation\n\nEither Eye:\n\n* Aphakia or absence of the posterior capsule\n* Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results\n* Corneal ECD ≤1500 cells\u002Fmm2 in either eye at screening as determined by the independent reading center\n* Fuchs endothelial corneal dystrophy Grade ≥ 2\n* Previous corneal endothelial cell damage, including from blunt or surgical trauma\n* Any ocular condition that precludes obtaining an analyzable specular microscopy image\n* Active or history of corneal edema\n* Active or history of corneal dystrophies\n* Active or history of iridocorneal endothelial syndrome\n* Active or history of pseudoexfoliation syndrome\n* Active or history of herpetic keratitis or kerato-uveitis\n* Any active or history of uveitis\n* Active intraocular inflammation\n* Active or history of keratitis, scleritis, or endophthalmitis\n* Active ocular or periocular infection\n* Active or history of Sjogren's syndrome or keratoconjunctivitis sicca\n* Active or history of floppy eyelid syndrome\n* Active or history of chronic eye rubbing\n* Active thyroid eye disease\n\nConcurrent Systemic Conditions:\n\n* History of uncontrolled blood pressure\n* Active or history of autoimmune diseases such as rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegener's)\n* History of stroke within the last 3 months prior to screening\n* Uncontrolled atrial fibrillation within 3 months of screening\n* History of myocardial infarction within the last 3 months prior to screening\n* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications, in the opinion of the investigator\n* Current active systemic infection\n* Use of any systemic anti-VEGF agents\n* Chronic use of oral corticosteroids\n* Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 and a stable prostate-specific antigen for \\> 12 months\n* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month prior to screening (excluding vitamins and minerals)\n* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the screening visit\n* Requirement for continuous use of any medications or treatments indicated as prohibited therapy\n* Pregnant or breastfeeding, or intention to become pregnant during the study\n* Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test",{"count":416,"type":22},188,[418],"PHASE4","This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).",[421],"Neovascular Age-related Macular Degeneration","2026-06-10",{"date":356,"type":34},{"date":425,"type":34},"2021-12-14",{"date":427,"type":22},"2027-10-29",{"name":40,"class":41},51,{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":369,"minAge":19,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":447,"locationsCount":261},"100636604","phase-1-a-study-evaluating-the-safety-pharmacokinetics-and-preliminary-activity-of-gdc-1261-in-participants-with-advanced-or-metastatic-prostate-cancer-100636604","NCT07567846","A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer","A Phase I\u002FII Dose-escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Patients With Advanced or Metastatic Prostate Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C=1\n* Life expectancy is \\>= 3 months\n* Histologically or cytologically confirmed prostate adenocarcinoma\n* Disease progression during or following the direct prior line of therapy\n* Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy\n* Metastatic disease\n* Adequate end organ function\n\nExclusion Criteria:\n\n* Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives\n* Structurally unstable bone lesions suggest an impending fracture\n* Untreated central nervous system (CNS) metastases or leptomeningeal disease\n* Uncontrolled pain\n* History of malignancy within 5 years\n* Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection\n* Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results",{"count":438,"type":22},260,[25,26],"The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.",[375,376],"2026-06-09",{"date":379,"type":34},{"date":445,"type":34},"2026-04-29",{"date":147,"type":22},{"name":40,"class":41},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":455,"phases":4,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":459,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":462,"locationsCount":4},"100642180","expanded-access-program-to-provide-giredestrant-to-participants-with-er-her2--early-or-locally-advancedmetastatic-breast-cancer-100642180","NCT07643831","Expanded Access Program to Provide Giredestrant to Participants With ER+, HER2- Early or Locally Advanced\u002FMetastatic Breast Cancer","A Multicenter, Open-Label Expanded Access Program to Provide Giredestrant to Patients With ER+, HER2- Early or Metastatic Breast Cancer","General Inclusion Criteria:\n\n* Documented ER-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines (Allison et al 2020), defined as ≥1% of tumor cells stained positive, as documented through local laboratory testing of a primary disease specimen\n* Documented HER2-negative tumor according to ASCO\u002FCAP guidelines (Wolff et al. 2023), as documented through local laboratory testing of a primary disease specimen\n* Adequate hematologic and organ function at screening\n* Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to CTCAE v6.0 Grade 1 or better (except alopecia, Grade ≤2 peripheral neuropathy, or other toxicities not considered a safety risk for the participant per treating physician's judgment)\n* Agreement to adhere to the contraception requirements\n* For women: postmenopausal, premenopausal, or perimenopausal status, defined as follows:\n\n  1. Postmenopausal status, as defined by at least one of the following criteria: Amenorrhea for ≥12 continuous months with no identified cause other than menopause. If clinically justified or if there is any doubt of postmenopausal state, a high blood follicle-stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in participants who are not using hormonal contraception or hormonal replacement therapy. Further guidance for these exceptional circumstances is provided in \"Recommendations related to contraception and pregnancy testing in clinical trials\" (CTFG 2020). Documented bilateral oophorectomy (≥14 days prior to first treatment on Day 1 of Cycle 1 and recovery from surgery to baseline), hysterectomy, or bilateral salpingectomy.\n  2. Premenopausal or perimenopausal status, as defined by not meeting the above criteria for postmenopausal status.\n* For premenopausal or perimenopausal women and men (except men with documented bilateral orchiectomy): agreement to receive treatment with an approved luteinizing hormone-releasing hormone (LHRH) agonist for the duration of the EAP treatment LHRH agonist therapy may be initiated up to 28 days prior to Day 1 of Cycle 1 (or as per clinical practice for the selected agent). To minimize the potential decrease of LHRH agonist to subtherapeutic levels towards the end of the treatment cycle, monthly injections of LHRH agonist are preferred and must be synchronized with Day 1 of each 28-day cycle. Known allergy or hypersensitivity to LHRH agonist therapy is exclusionary.\n* Ability to swallow capsules or tablets intact, without chewing or crushing\n\nInclusion Criteria for Early Breast Cancer (eBC) Cohort:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* Definitive surgery of primary breast tumor(s) and axillary lymph nodes dissection (ALND) and\u002For sentinel lymph node biopsy (SLNB)\n* For individuals who have received neoadjuvant chemotherapy and\u002For had definitive breast cancer surgery and no prior endocrine therapy: surgery must have been performed within 12 months prior to enrollment\n* For individuals who have received adjuvant chemotherapy: adjuvant chemotherapy must have been completed prior to enrollment. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and enrollment in EAP.\n* Stage I, II, or III breast cancer, with medium or high risk of recurrence\n\nInclusion Criteria for Locally Advanced\u002FMetastatic Breast Cancer (LA\u002FmBC) Cohort:\n\n* Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Disease progression after ≥6 months on endocrine therapy (ET) plus cyclin-dependent kinase 4\u002F6 inhibitor (CDK4\u002F6i) in the LA\u002FmBC setting, or recurrence while taking or within 12 months of taking combination adjuvant ET plus CDK4\u002F6i\n* Documentation of the presence of a ESR1 mutation\n\nGeneral Exclusion Criteria:\n\n* Previous enrollment in Roche- or Genentech-sponsored study of giredestrant\n* Current participation in any ongoing Roche- or Genentech-sponsored clinical study of giredestrant\n* Eligible for participation in any ongoing Roche- or Genentech-sponsored clinical study of giredestrant\n* Inability to comply with EAP and follow-up procedures\n* Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of EAP treatment\n* Treatment with any investigational therapy within 28 days prior to initiation of EAP treatment\n* Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 21 days prior to initiation of EAP treatment\n* History of any other malignancy other than breast cancer within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, Stage I endometrial cancer, or other non-breast cancers at very low risk of recurrence per treating physician's judgment\n* Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a history of CNS metastases or cord compression are eligible if have been definitively treated with local therapy (e.g., radiotherapy, surgery), are clinically stable, and have not been treated with anticonvulsants or corticosteroids within 2 weeks prior to initiation of EAP treatment\n* Active cardiac disease or history of cardiac dysfunction\n* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (ex: hepatitis B \\[HBV\\] or hepatitis C \\[HCV\\]) virus, current alcohol abuse or cirrhosis\n* Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy\n* Serious infection requiring oral or IV antibiotics, or other clinically significant infection, within 14 days prior to initiation of EAP treatment\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the treating physician's judgment, precludes the participant's safe participation in and completion of the EAP\n* Known allergy or hypersensitivity to any of the EAP drugs or any of their excipients\n* Pregnant or breastfeeding, or intending to become pregnant during the EAP or within the timeframe in which contraception is required\n\nExclusion Criteria for eBC Cohort:\n\n* Current treatment or planned treatment with CDK4\u002F6i as neoadjuvant or adjuvant therapy. A short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4\u002F6i therapy prior to enrollment is allowed. A washout period of approximately 7 days is required between the last dose of CDK4\u002F6i therapy and enrollment.\n* History of \\>12 weeks of any endocrine treatment with selective ER modulator (e.g., tamoxifen), degrader, or aromatase inhibitor\n\nExclusion Criteria for LA\u002FmBC Cohort:\n\n* Progression on more than two prior lines of systemic ET in the locally advanced unresectable or metastatic breast cancer setting\n* Prior treatment with an oral selective estrogen receptor degrader (SERD), proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), novel oral selective estrogen receptor modulator (SERM), or everolimus in any setting\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term (including massive uncontrolled effusions \\[pleural, pericardial, peritoneal\\] or pulmonary lymphangitis)\n* Known positive HIV status and meeting any of the following criteria: CD4+ T-cell count of \\\u003C350 cells\u002FuL; Detectable HIV viral load; History of an opportunistic infection within the past 12 months; On stable antiretroviral therapy for \\\u003C4 weeks\n* Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection, potentially affecting enteral absorption, or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea","EXPANDED_ACCESS","The primary objective of this expanded access program (EAP) is to provide early access to giredestrant for participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (eBC) or locally advanced\u002Fmetastatic breast cancer (LA\u002FmBC) prior to commercial availability in the United States.",[458],"ER+\u002FHER2- Early or Locally Advanced\u002FMetastatic Breast Cancer","AVAILABLE","2026-06-08",{"date":356,"type":34},{"name":40,"class":41},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":482},"100513657","phase-2-a-study-of-the-efficacy-and-safety-of-adjuvant-autogene-cevumeran-plus-atezolizumab-and-mfolfirinox-versus-mfolfirinox-alone-in-participants-with-resected-pdac-100513657","NCT05968326","A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC","A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma","IMCODE003","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of PDAC\n* Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual\n* Macroscopically complete (R0 or R1) resection of PDAC\n* Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to treatment initiation\n* CA19-9 level measured within 14 days prior to initiation of study treatment\n* Interval of between 6 and 12 weeks since resection of PDAC\n* Full recovery from surgery and ability to receive atezolizumab, autogene cevumeran, and mFOLFIRINOX in the investigator's judgment\n* Adequate hematologic and end-organ function\n* Female participants of childbearing potential must be willing to avoid pregnancy during the treatment period and for 28 days after the final dose of autogene cevumeran, for 9 months after the last dose of chemotherapy, and for 5 months after the final dose of atezolizumab. They must refrain from donating eggs for 9 months after the last dose of chemotherapy.\n* Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use specified contraceptive methods during the treatment period and for 28 days after the final dose of autogene cevumeran and for 6 months after the last dose of chemotherapy. Men must refrain from donating sperm during this same period.\n\nExclusion Criteria:\n\n* Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer\n* Plan for further adjuvant anti-cancer therapy for PDAC (e.g., radiotherapy and\u002For chemotherapy), not mandated per protocol, to be initiated after completion of mFOLFIRINOX treatment\n* Absence of spleen; distal pancreatectomy with splenectomy is exclusionary\n* Preexisting Grade \\>\u002F=2 neuropathy\n* Known complete dihydropyrimidine dehydrogenase (DPD) deficiency including homozygous or compound heterozygous mutations of DPYD genetic locus associated with DPD deficiency\n* Disorders of the colon or rectum, or postoperative complication leading to Grade \\>\u002F=2 diarrhea\n* Pregnancy or breastfeeding\n* Active or history of autoimmune disease or immune deficiency\n* Treatment with brivudine, sorivudine, or their chemically-related analogues, which are inhibitors of DPD, within 4 weeks prior to initiation of study treatment\n* Current or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and\u002For uridine diphosphate glucoronosyltransferase 1A1 (UGT1A1).",{"count":438,"type":22},[26],"The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.",[475],"Adenocarcinoma, Pancreatic Ductal",{"date":442,"type":34},{"date":478,"type":34},"2023-10-18",{"date":480,"type":22},"2031-01-01",{"name":40,"class":41},89,{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":171},"100483897","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-enzelkitug-as-a-single-agent-and-in-combination-with-checkpoint-inhibitor-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100483897","NCT05581004","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase Ia\u002FIb, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Life expectancy of at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\n* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy\n* Tumor specimen availability\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and\u002For radiotherapy, within 3 weeks prior to initiation of study treatment\n* Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis\n* Positive test for human immunodeficiency virus (HIV) infection\n* Acute or chronic active Epstein-Barr virus (EBV) infection at screening\n* Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease\n* Prior allogeneic stem cell or organ transplantation",{"count":491,"type":22},450,[25],"This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.",[495,496,497,498,499,500,501,502,503,504,505,138],"Locally Advanced or Metastatic Solid Tumors","NSCLC","HNSCC","Melanoma","TNBC","Esophageal Cancer","Gastric Cancer","Cervical Cancer","Colorectal Cancer","Urothelial Carcinoma","Clear Cell RCC",{"date":442,"type":34},{"date":508,"type":34},"2022-10-20",{"date":510,"type":22},"2028-07-31",{"name":40,"class":41},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":23,"phases":522,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":532},"100385693","phase-2-a-study-of-multiple-therapies-in-biomarker-selected-participants-with-resectable-stages-ib-iii-non-small-cell-lung-cancer-nsclc-100385693","NCT04302025","A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)","NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer","NAUTIKA1","Inclusion Criteria for Neoadjuvant Therapy:\n\n* Pathologically documented NSCLC:\n* Newly diagnosed early-stage NSCLC stages IB, IIA, IIB, IIIA, or selected IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the American Joint Committee on Cancer (AJCC)\u002FUnion Internationale Contre le Cancer (UICC) NSCLC staging system\n* T4 primary NSCLC will be allowed only on the basis of size. Invasion of the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina, and separate tumor nodules in a different ipsilateral lobe is not permitted\n* All participants will undergo clinical staging using computed tomography (CT) and positron emission tomography (PET) scanning, as well as brain imaging using magnetic resonance imaging (MRI). Invasive mediastinal staging by either mediastinoscopy or endo-bronchial ultrasonography is highly encouraged for participants with radiographically suspected mediastinal nodal disease (i.e., N2) but not mandated if the CT or PET scans showed no evidence of N2 disease\n* Molecular testing results from clinical laboratory improvement amendments (CLIA)-certified laboratories and showing at least one of the following abnormalities: ALK fusion, ROS1 fusion, NTRK1\u002F2\u002F3 fusion; BRAF V600 mutation, RET fusion, PD-L1 expression in ≥ 1% tumor cells as determined by Food and Drug Administration (FDA)-approved test, KRAS G12C mutation\n* Measurable disease, as defined by RECIST v1.1\n* NSCLC must have a solid or subsolid appearance on CT scan and cannot have a purely ground glass opacity appearance. For subsolid lesions, the tumor size (i.e., clinical T stage) should be measured based on the solid component only, exclusive of the ground glass opacity component\n* Evaluated by the attending surgeon prior to study enrollment to verify that the primary tumor and any involved lymph nodes are technically completely resectable and verify that the participant is medically operable\n* Adequate pulmonary function to be eligible for surgical resection with curative intent\n* Adequate cardiac function to be eligible for surgical resection with curative intent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate hematologic and end-organ function\n* Negative hepatitis B surface antigen (HBsAg) test at screening for cohort\n* Negative total hepatitits B core antibody (HBcAb) test at screening for cohort, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test at screening\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening\n* Male participants must be willing to use acceptable methods of contraception\n* Female participants of childbearing potential must agree to use acceptable methods of contraception\n\nInclusion Criteria for Adjuvant Therapy (TKI Cohorts and KRAS G12C cohort \\[if continuing on Divarasib\\]):\n\n* Participants whose tumors lack radiographic progression\n* ECOG Performance Status of 0 or 1\n* Adequate hematologic and end-organ function\n\nExclusion Criteria\n\n* NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease\n* Any prior therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 2 years\n* Participants with prior lung cancer\n* Major surgical procedure within 28 days prior to Cycle 1, Day 1\n* Malignancies other than the disease under study within 3 years prior to Cycle 1, Day 1, with the exception of participants with a negligible risk of metastasis or death and with expected curative outcome\n* Treatment with an investigational agent for any condition within 4 weeks prior to Cycle 1, Day 1\n* Participants known to be positive for human immunodeficiency virus (HIV) are excluded if they meet any of the following criteria: cluster of differentiation 4 (CD4)+ T-cell count of \\\u003C350 cells\u002Fmicroliters (cells\u002FµL); detectable HIV viral load; history of an opportunistic infection within the past 12 months; on stable antiretroviral therapy for \\\u003C4 weeks\n* Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact participant safety\n* Pregnant or lactating, or intending to become pregnant during the study",{"count":521,"type":22},99,[26],"This trial will evaluate the efficacy and safety of various therapies in participants with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated NSCLC tumors that meet protocol-specified biomarker criteria.",[525],"Non-small Cell Lung Cancer",{"date":442,"type":34},{"date":528,"type":34},"2020-11-06",{"date":530,"type":22},"2030-05-30",{"name":40,"class":41},38,{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":222,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":540,"targetDuration":4,"studyType":23,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":85},"100604022","phase-1-a-study-to-evaluate-the-effect-of-moderate-or-severe-hepatic-impairment-on-the-pharmacokinetics-pk-of-inavolisib-100604022","NCT07144111","A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib","Inclusion Criteria:\n\nAll participants:\n\n* Body Mass Index 18.0 to 40.0 kilogram per meter square (kg\u002Fm\\^2), inclusive, and body weight \\>=45 kg.\n* Negative hepatitis B surface antigen (HBsAg) test\n* Positive hepatitis B surface antibody (HBsAb) test or negative HBsAb\n* Negative HIV (Human Immunodeficiency Virus) test\n* Females will not be pregnant or breastfeeding and must be either postmenopausal or surgically sterile\n* Males will agree to use contraception and will refrain from sperm donation\n\nHealthy participants (Cohort 1):\n\n* Negative hepatitis C virus (HCV) antibody test or positive HCV antibody test followed by a negative HCV RNA test\n* Normal hepatic function and no history of clinically significant hepatic dysfunction\n\nParticipants with Hepatic Impairment (Cohorts 2 and 3):\n\n* Considered to have moderate (Child-Pugh score of 7 to 9) or severe (Child-Pugh score of 10 to 15) hepatic impairment\n* Chronic, stable hepatic insufficiency with features of cirrhosis\n* Negative hepatitis C viral load\n\nExclusion Criteria:\n\nAll participants:\n\n* History of Type 1 diabetes or Type 2 Diabetes that is insulin-dependent or requires ongoing systemic treatment with two or more agents\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder\n* Significant illness, surgery, or hospitalization within 2 weeks prior to dosing.\n* History of gastro-intestinal surgery\n* Malabsorption syndrome or any other condition that would interfere with enteral absorption.\n* History of active or latent Mycobacterium tuberculosis (TB), regardless of treatment history, or positive QuantiFERON® TB Gold test\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance\n* Use of drugs of abuse (including opioids)\n\nHealthy participants (Cohort 1):\n\n\\- History of alcoholism or drug addiction\n\nParticipants with Hepatic Impairment (Cohorts 2 and 3):\n\n* Hepatic impairment due to hepatocellular carcinoma or bile duct cancer\n* Surgical or artificial portosystemic shunt (e.g., transjugular intrahepatic portosystemic shunt)\n* Evidence of hepatorenal syndrome\n* Ascites requiring paracentesis\n* Any evidence of progressive liver disease in the last 1 month\n* Receipt of a liver transplant\n* Hepatic encephalopathy Grade 2 or above",{"count":541,"type":22},32,[25],"This open-label study will evaluate the effect on the pharmacokinetics (PK), safety, and tolerability of a single oral dose of inavolisib in participants with moderate or severe hepatic impairment compared with demographically matched healthy participants with normal hepatic function.",[545],"Hepatic Impairment","2026-06-04",{"date":460,"type":34},{"date":549,"type":34},"2025-08-21",{"date":551,"type":22},"2026-09-06",{"name":40,"class":41},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":574},"100562444","phase-1-a-study-to-test-the-safety-and-effects-of-inhaled-gdc-6988-in-participants-with-muco-obstructive-disease-100562444","NCT06603246","A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease","A Phase Ic, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-obstructive Disease","Inclusion Criteria:\n\n* Percent predicted FEV1 ≥ 40% by spirometry during screening\n* Ability to demonstrate correct use of the smart DPI at screening, in the investigator's judgment\n* On a stable treatment regimen for muco-obstructive diseases for ≥ 28 days prior to initiation of study treatment and willingness to remain on the stable treatment regimen through completion of study\n* Stable disease for ≥ 28 days prior to screening and through to initiation of study treatment\n\nAdditional Inclusion Criteria for Participants in Part B\n\n* Chronic sputum production of ≥1 teaspoon per day as reported in the sputum volume item\n* Ability to produce a sputum sample that is suitable for central laboratory determination of mucus percent solids and sialic acid concentration exploratory biomarker research, and biomarker assay development\n* Availability of a representative blood sample for exploratory biomarker research and biomarker assay development\n\nAdditional Inclusion Criteria for Participants With Non-cystic Fibrosis Bronchiectasis (NCFB) (Cohort 1, Cohort 2, and Cohort 3):\n\n\\- Diagnosis of bronchiectasis on the basis of prior chest computed tomography (CT), involving at least 2 lobes, with at least one lobe of involvement in the right lung as assessed by the investigator\n\nAdditional Inclusion Criteria for Participants With Chronic Obstructive Pulmonary Disease (COPD) (Cohort 1, Cohort 2, and Cohort 4):\n\n* COPD defined as post-bronchodilator FEV1\u002FFVC ratio of \\\u003C0.7\n* Chronic bronchitis, with a definition including chronic cough and excessive sputum production for more than 3 months per year for at least 2 years prior to screening\n* Former smoker with a minimum of 10 pack-year history (e.g., 20 cigarettes\u002Fday for 10 years) or non-smoker with at least one documented COPD risk factor\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the timeframe in which contraception is required\n* Known significant bronchodilator response of \\>10% predicted change in FEV1 or FVC, in the investigator's judgment\n* Use of any prohibited medications\n* Acute respiratory infection within 28 days of screening\n* Significant hemoptysis greater than 60 milliliter (mL) within 3 months prior to screening\n* Known immunodeficiency that, in the investigator's judgment, is clinically significant and places the individual at a substantially elevated risk for opportunistic infections.\n* Known substance abuse, in the investigator's judgment, within 12 months prior to screening\n* Poor peripheral venous access\n* Receipt of blood products within 120 days prior to screening\n* Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results\n* History of thoracic or metastatic malignancy within 5 years prior to screening\n* Known history of a clinically significant abnormal electrocardiogram (ECG), or presence of an abnormal ECG that is deemed clinically significant by the investigator\n* QT interval corrected through use of Fridericia's formula (QTcF) \\>450 milliseconds (ms) for males or \\>470 ms for females\n\nAdditional Exclusion Criteria for Participants in Part B -More than 2 chest CTs or other procedures known to expose the lungs to greater than 100 millisievert (mSv) within 12 months prior to screening\n\nAdditional Exclusion Criteria for Participants With NCFB (Cohort 1, Cohort 2, and Cohort 3)\n\n* Bronchiectasis primarily due to cystic fibrosis, primary ciliary dyskinesia, non-tuberculous mycobacterial infection, chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD), in the investigator's judgment\n* Diagnosis of asthma, that in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary asthma with incidental bronchiectasis findings)\n* NCFB exacerbation within 28 days prior to screening or that has not returned to baseline\n* Current smoker: Current smoking is defined as any use of inhaled tobacco products or inhaled marijuana within 3 months prior to screening, through use of cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipes.\n\nAdditional Exclusion Criteria for Participants with NCFB in Cohort 3\n\n\\- Diagnosis of COPD that, in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary COPD with incidental bronchiectasis findings)\n\nAdditional Exclusion Criteria for Participants With COPD (Cohort 1, Cohort 2, and Cohort 4):\n\n* COPD exacerbation within 28 days prior to screening or that has not returned to baseline\n* Asthma\u002FCOPD overlap syndrome",{"count":561,"type":22},128,[25],"This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.",[565,566],"Non-cystic Fibrosis Bronchiectasis","Chronic Obstructive Pulmonary Disease","2026-06-02",{"date":546,"type":34},{"date":570,"type":34},"2024-11-18",{"date":572,"type":22},"2027-11-15",{"name":40,"class":41},7,""]