[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AstraZeneca\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":667},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,290,0,25,[9,48,76,100,123,149,178,206,237,275,305,336,361,382,404,426,450,470,496,524,552,575,599,622,644],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":26,"briefSummary":29,"conditions":30,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053463","phase-1-a-study-to-evaluate-azd7760-safety-and-pharmacokinetics-in-healthy-adults-phase-i-and-adults-with-end-stage-kidney-disease-on-hemodialysis-with-a-central-venous-catheter-phase-iia-100053463",false,"NCT06749457","A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)","A Phase I\u002FIIa Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Participants and in Patients With End-stage Kidney Disease Receiving Hemodialysis Through a Central Venous Catheter","PEAK","Inclusion Criteria:\n\nPhase I:\n\n* Participant must be 18 to 55 years of age (inclusive), at the time of signing the informed consent.\n* Body weight ≥ 45 kilograms (kg) and ≤ 110 kg and Body Mass Index (BMI) within the range ≥ 18.0 to ≤ 30.0 kilograms per square meter (kg\u002Fm2) (inclusive) at screening.\n* Healthy participants with no clinically significant concomitant diseases or medications (except for those specifically permitted by the protocol) according to medical history, physical examination, screening safety laboratory tests, and screening parameters, as perthe judgement of the investigator.\n\nPhase IIa:\n\n* Participant must be ≥ 18 years of age at the time of signing the informed consent.\n* Participants who meet all of the following disease status requirements:\n\n  1. Diagnosed with End-stage kidney disease (ESKD).\n  2. Requiring hemodialysis through a tunneled central venous catheter as the primary vascular access for hemodialysis.\n  3. Receiving hemodialysis for treatment of ESKD for at least 90 days before randomization.\n  4. At least 3 previous dialysis sessions using current dialyzer.\n  5. Receiving adequate hemodialysis based on a single-pool Kt\u002FV measurement \\> 1.2 within the last 30 days.\n  6. No new medications have been added to the participant's regimen in the last 2 weeks prior to dosing. 'New medication' is defined as any medication that has not been prescribed or used by the participant previously (including formulation changes). Medication previously prescribed or used by the participant with dose adjustments is allowed and not considered as new medication for the purpose of this study.\n  7. Not taking long-term systemic antibiotics with activity against S aureus.\n\nExclusion Criteria:\n\nPhase I:\n\n* Known hypersensitivity to any component of the study intervention\n* Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal antibodies (mAbs).\n* Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.\n* Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) above 1.5 × upper limit of normal (ULN) at screening. Testing may be repeated once at the investigator's discretion.\n* Estimated glomerular filtration rate \\\u003C 90 mL\u002Fmin\u002F1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at screening.\n* Hemoglobin or platelet count below the lower limit of normal at screening. Testing may be repeated once at the investigator's discretion.\n* White blood cell counts outside normal reference ranges unless judged by the investigator to be out of range given the known variation in white blood cell count reference interval by ethnicity. Testing may be repeated once at the investigator's discretion.\n* History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.\n* Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.\n* Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening, as judged by the investigator.\n* Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the 28-day Screening Period or may be rescreened once.\n* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.\n* Any condition that has the potential to increase clearance of the study intervention (eg, protein loss conditions such as severe enteropathies, or plasmapheresis).\n* Blood drawn in excess of a total of 450 milliliters (mL) (1 unit) for any reason within 2 months prior to screening.\n* Absence of suitable veins for blood sampling and administration of study intervention.\n* Any other condition that would compromise safety of the participants.\n* Any condition that, in the opinion of the investigator, might interfere with evaluation of the study intervention or interpretation of participant safety or study results.\n\nPhase IIa:\n\n* Known hypersensitivity to any component of the study intervention.\n* History of allergic disease or reactions likely to be exacerbated by any component of the study intervention as listed in dose formulation section.\n* Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.\n* Hemoglobin \\\u003C 9 g\u002FdL at screening considered by the investigator to be due to acute condition(s). Testing may be repeated once at the investigator's discretion.\n* Serum albumin of \\\u003C 3 g\u002FdL at screening considered by the investigator to be due to acute condition(s). Testing may be repeated once at the investigator's discretion.\n* Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic\u002Fthromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 90 days prior to randomization.\n* Known S aureus infection within 90 days of study entry.\n* Known acute viral or bacterial infection or symptoms\u002Fsigns consistent with such an infection within the 21 days prior to infusion or study intervention. Mild intercurrent viral illness with a temperature of 38.1 °C (100.6 °F) or less does not require exclusion, if in the judgement of the investigator this illness will not interfere with the evaluation of the mAb.\n* Participants with malignancy undergoing chemotherapy.\n* Scheduled date for living donor kidney transplant.\n* Plans to switch to peritoneal dialysis within the primary endpoint time period (181 days).\n* Participants with a scheduled calendar date for transition to arteriovenous graft or arteriovenous graft in place and maturing.\n* Participants with a scheduled calendar date for transition to arteriovenous fistula, or arteriovenous fistula in place and maturing, with anticipated use of fistula within 90 days.",true,"ALL","18 Years","55 Years",{"count":23,"type":24},231,"ESTIMATED","INTERVENTIONAL",[27,28],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of AZD7760 when given as an intravenous infusion to healthy participants (Phase I) or participants with end-stage kidney disease receiving hemodialysis through a central venous catheter (Phase IIa).",[31],"Staphylococcus Aureus",[33,34],"Bloodstream infection","End-stage kidney disease","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2024-12-30",{"date":43,"type":24},"2028-01-07",{"name":45,"class":46},"AstraZeneca","INDUSTRY",43,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":56,"minAge":20,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":25,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100053507","phase-1-first-in-human-study-to-evaluate-azd8359-steap2-tce-in-participants-with-prostate-cancer-100053507","NCT07529717","First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer","Phase I\u002FII Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer","CRIUS-1","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer\n* Surgically or medically castrated with serum testosterone levels ≤ 50 ng\u002FdL (≤ 1.75 nmol\u002FL)\n* PSA value at screening should be ≥ 1ng\u002FmL\n* Evidence of disease progression within 6 months prior to screening\n* Part A Participants should have received at least 2 prior approved systemic therapies for prostate cancer with at least one androgen receptor pathway inhibitor and at least one taxane regimen if amenable\n* Part B Participants should have received an androgen receptor pathway inhibitor for metastatic hormone sensitive prostate cancer or metastatic castration resistant prostate cancer (mCRPC). No prior taxane treatment for mCRPC is allowed for Module 1 and 2 Part B patients\n* Adequate organ function\n* Body weight ≥ 35 kg\n\nExclusion Criteria:\n\n* Any clinically relevant cardiac abnormalities such as QT prolongation or uncontrolled cardiac arrythmias\n* All prior treatment-related adverse events must have resolved to Grade ≤ 2\n* History of Grade ≥ 3 cytokine release syndrome or Grade ≥ 2 immune effector cell-associated neurotoxicity syndrome with prior therapy\n* Active or prior documented autoimmune or inflammatory disorders within the past 3 years\n* Prior exposure to any STEAP2 targeted agents or TCEs for prostate cancer","MALE","100 Years",{"count":59,"type":24},42,[27,28],"This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD8359. The study is split into different modules which will look at AZD8359 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels and dosing schedules of AZD8359 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD8359 doses in a larger group of participants (dose expansion).",[63],"Metastatic Prostate Cancer",[65,66,67,68],"Prostate","STEAP2","T Cell-engaging Antibody","CD8",{"date":38,"type":39},{"date":71,"type":39},"2026-05-18",{"date":73,"type":24},"2027-11-17",{"name":45,"class":46},8,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":25,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100053708","phase-1-a-study-of-azd3470-a-prmt5-inhibitor-given-as-monotherapy-and-in-combination-in-patients-with-mtap-deficient-advancedmetastatic-solid-tumors-100053708","NCT06130553","A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced\u002FMetastatic Solid Tumors","PRIMROSE: A Modular Phase I\u002FIIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced\u002FMetastatic Solid Tumors That Are MTAP Deficient","PRIMROSE","Inclusion Criteria (All Modules) Participants are ≥ 18 years (or the legal age of consent in the jurisdiction) at the time of signing the informed consent form.\n\nParticipants are able to provide written informed consent and are willing and able to comply with study procedures.\n\nParticipants are willing to provide archival and\u002For newly obtained (baseline) tumor tissue for central testing, including required biomarker assessment(s) (and any module-specific biomarker requirements).\n\nParticipants have tumors meeting the protocol-defined MTAP-deficiency requirement, based on acceptable prior testing and\u002For central testing per protocol.\n\nParticipants have received prior systemic therapy appropriate for the tumor type and disease stage and have disease progression on or after prior therapy; participants must have had ≥ 1 prior line of systemic treatment in the recurrent\u002Fmetastatic (advanced) setting.\n\nParticipants have ECOG performance status 0-1. Participants have life expectancy ≥ 12 weeks, in the opinion of the Investigator.\n\nParticipants have measurable disease per RECIST v1.1. Participants have adequate organ and bone marrow function per protocol-defined laboratory\u002Fassessment criteria.\n\nParticipants have a treatment-free interval ≥ 3 weeks from prior anticancer therapy before starting study drug (with any additional protocol-defined washout requirements for certain therapies\u002Fprocedures).\n\nContraception use by men and women is consistent with local regulations and protocol-defined requirements.\n\nAdditional Inclusion Criteria (Module 2: Non-squamous NSCLC) Participants have histologically or cytologically confirmed non-squamous NSCLC, Stage IIIB\u002FIIIC not amenable to curative therapy or Stage IV.\n\nParticipants have documented radiographic extracranial disease progression while on or after the most recent treatment regimen for advanced\u002Fmetastatic NSCLC (CNS-only progression is not eligible).\n\nNSCLC of mixed histology is allowed if not predominantly squamous; no small cell or large cell neuroendocrine components.\n\nParticipants meet one of the following:\n\nTumor has a documented EGFR alteration eligible for EGFR-directed therapy (per protocol-defined criteria) and the participant has received prior systemic therapy appropriate for EGFR-altered advanced\u002Fmetastatic NSCLC (per protocol), OR Tumor is negative for EGFR alterations eligible for EGFR-directed therapy, has no other known actionable genomic alterations for which locally approved\u002Favailable targeted therapies exist (per protocol-defined criteria), meets any additional protocol-required biomarker criteria for this cohort (as applicable), and the participant has received prior systemic therapy appropriate for non-actionable-alteration advanced\u002Fmetastatic NSCLC (per protocol).\n\nExclusion Criteria (All Modules) Participants have spinal cord compression, or symptomatic and unstable brain metastases, leptomeningeal disease, or primary CNS malignancy. Participants with asymptomatic, radiographically stable brain metastases who do not require steroids (or who have completed definitive therapy and are neurologically stable off steroids, per protocol) may be eligible.\n\nParticipants have a history of allogeneic organ transplantation. Participants have any clinically significant abnormal laboratory finding or severe and uncontrolled medical condition that, in the Investigator's opinion, makes participation unsafe, including active infection requiring systemic treatment.\n\nParticipants have clinically significant cardiovascular disease or risk factors (including reduced LVEF, cardiomyopathy, clinically active cardiovascular disease, recent major ischemic events or revascularization procedures, uncontrolled angina, severe valvular disease, uncontrolled hypertension, clinically significant heart failure, or recent stroke\u002FTA clinically significant ECG abnormalities, prolonged QTc, or conditions\u002Fmedications that increase risk of QTc prolongation or arrhythmic events)..\n\nParticipants require therapeutic anticoagulation for treatment of acute thromboembolic events, per protocol.\n\nParticipants have active hepatitis B or hepatitis C infection (including detectable viral load, per protocol-defined testing).\n\nParticipants have known HIV infection. Participants have current ILD\u002Fpneumonitis, or a history of (non-infectious) ILD\u002Fpneumonitis requiring systemic steroids or supplemental oxygen, or suspected ILD\u002Fpneumonitis that cannot be ruled out by screening imaging.\n\nParticipants have active gastrointestinal disease, malabsorption, or other GI condition\u002Fsurgery that would significantly interfere with oral drug absorption or tolerability.\n\nParticipants have a history of another primary malignancy. Participants have unresolved clinically significant toxicity from prior anticancer therapy (typically Grade ≥ 2).\n\nParticipants have had prior treatment with a PRMT5 inhibitor Participants are pregnant, breastfeeding, or intend to become pregnant during study participation.\n\nAdditional Exclusion Criteria (Module 2 Only) Participants have inaccessible veins and\u002For inability to place required venous access (e.g., port), per Investigator judgment.\n\nParticipants have contraindication to required CNS imaging (brain MRI preferred or CT with contrast).\n\nParticipants have clinically significant corneal disease. Participants have known active tuberculosis infection, per clinical evaluation and local practice.\n\nParticipants have significant third-space fluid (e.g., pleural effusion\u002Fascites) not amenable to required repeated drainage, per Investigator judgment.\n\nParticipants have severe pulmonary function compromise due to intercurrent pulmonary illness (e.g., severe COPD\u002Fasthma\u002Frestrictive lung disease, recent pulmonary embolism), per protocol.\n\nParticipants have recent radiotherapy that does not meet protocol-defined washout requirements and\u002For ongoing radiation-related toxicities requiring corticosteroids.\n\nParticipants have had prior treatment with protocol-prohibited anticancer therapies.",{"count":85,"type":24},334,[27,28],"This is a first time in human (FTiH) Phase I\u002FIIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.",[89],"Advanced Solid Tumors That Are MTAP Deficient",[91,92],"solid tumor","MTAP deficient",{"date":38,"type":39},{"date":95,"type":39},"2024-01-18",{"date":97,"type":24},"2028-12-04",{"name":45,"class":46},21,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100053914","choicedecision-factor-of-egfr-tki-in-chinese-iv-nsclc-100053914","NCT07413757","CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC","A Cross-sectional Survey-based Study Using Preference Elicitation Method to Assess Decision-making Impact Factor of Chinese Patients and Physicians for First-line EGFR-TKIs Treatment of Stage IV NSCLC (CHOICE)","CHOICE","Inclusion Criteria:\n\nThe following inclusion criteria must be met in order to be enrolled in the stage 1:\n\nPatient:\n\n* Provide informed consent\n* 18 years or older\n* Diagnosed with stage IV NSCLC\n* Currently receiving or previously received 1L EGFR-TKI treatment\n* Without communication barrier\n* Do not exhibit signs of cognitive impairment that would prevent participation in an interview, as informally assessed during screening by the recruiter\n\nPhysician:\n\n* Provide informed consent\n* Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals\n* Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month\n* Holding the title of associate chief physician or higher\n\nThe following inclusion criteria must be met in order to be enrolled in the stage 2:\n\nPatient:\n\n* Provide informed consent\n* 18 years or older\n* Diagnosed with stage IV NSCLC\n* Currently receiving or previously received 1L EGFR-TKI treatment\n* Without communication barrier\n* Do not exhibit signs of cognitive impairment that would prevent participation in a survey, as informally assessed during screening by the recruiter\n\nPhysician:\n\n* Provide informed consent\n* Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals\n* Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month\n* Holding the title of attending physician or higher\n\nExclusion Criteria:\n\nNot applicable.",{"count":109,"type":24},590,"OBSERVATIONAL","This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.",[113],"Non-Small Cell Lung Cancer",[115],"NSCLC;patients and physicians;survey;EGFR-TKI;patient preference;physician preference",{"date":38,"type":39},{"date":118,"type":39},"2026-03-02",{"date":120,"type":24},"2026-07-31",{"name":45,"class":46},1,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":122},"100054280","aqualisqol-of-cll-patients-treated-with-acalabrutinib-in-france-retrospective-study-based-on-data-from-platon-database-100054280","NCT06548152","AQUALIS:QoL of CLL Patients Treated With Acalabrutinib in France, Retrospective Study Based on Data From PLATON Database","AQUALIS: Quality of Life of Patients With Chronic Lymphocytic Leukemia Treated With Acalabrutinib in France: a Retrospective Observational Study Based on Data Extracted From the PLATON Database","AQUALIS","Inclusion criteria:\n\nThe following patients will be eligible for inclusion in the AQUALIS study :\n\n* Patient enrolled in the PLATON database\n* Patient ≥18 years old\n* Treatment naïve CLL patient treated with acalabrutinib in a real life setting. Treatment pattern is Acala mono or Acala + Obinutuzumab\n* Patient who do not object to his health data collected in PLATON study being re-use for analysis\u002Fresearch purpose\n* Patients who started Acala but discontinued before 12 months are also included.\n\nExclusion criteria:\n\n* Pregnant women\n* Patients under protection of justice\n* Patients over the age of 18 and unable to express their non-opposition\n* Patients with prior CLL treatments",{"count":132,"type":24},120,"QoL is often not assessed in real-world studies; hence, there is limited understanding about the real-world QoL of patients diagnosed with CLL. Besides, studies evaluating QoL have largely focused on comparing treated and untreated populations. In particular, QoL of patients treated with acalabrutinib has not been evaluated in a real-life setting.\n\nThe aim of this study is to describe the QoL of CLL patients treated with acalabrutinib between the treatment initiation and twelve months after, in a real-life setting.",[135],"Chronic Lymphocytic Leukemia",[137,138,139,140,141,142],"Chronic Lymphocytic Leukemia (LLC)","Quality of life","Acalabrutinib","France","Retrospective observational study","PLATON database",{"date":38,"type":39},{"date":145,"type":39},"2025-04-28",{"date":147,"type":24},"2026-12-31",{"name":45,"class":46},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":25,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100054276","phase-2-a-study-of-novel-study-interventions-and-combinations-in-participants-with-colorectal-cancer-100054276","NCT06792695","A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer","A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)","CANTOR","Overall Inclusion Criteria:\n\n* Histopathologically confirmed colorectal adenocarcinoma.\n* Provision of FFPE tumor sample collected as per SoC.\n* Presence of measurable disease by RECIST 1.1 criteria.\n* ECOG performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks at the time of screening.\n\nSubstudy Inclusion Criteria:\n\n* No radiological evidence of liver metastasis.\n* No prior systemic therapy for mCRC, except for neoadjuvant\u002Fadjuvant chemotherapy where, \\> 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease.\n* Known pMMR\u002FMSS status (only pMMR\u002FMSS mCRC allowed).\n* Adequate organ and bone marrow function\n* Body weight \\> 35 kg at screening and at randomization.\n* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nOverall Exclusion Criteria:\n\n* Central nervous system metastases or spinal cord compression\n* Known history of severe allergy to any monoclonal antibody or study intervention.\n* Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy.\n* History of another primary malignancy.\n\nSubstudy Exclusion Criteria:\n\n* Potentially resectable disease with multidisciplinary plan for radical surgery.\n* Active or prior documented autoimmune or inflammatory disorders or cardiac conditions.\n* Participants with a prior history of hypertensive crisis or hypertensive encephalopathy or bleeding risks.\n* Deep venous thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic attack or cerebrovascular accident.\n* History of abdominal or tracheoesophageal fistula, GI perforation and\u002For fistulae, or intraabdominal abscess within 6 months prior to randomization.\n* Prior exposure to immune mediated therapy.","130 Years",{"count":159,"type":24},80,[28],"The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).",[163],"Metastatic Colorectal Cancer",[165,166,167,168,169,170,155],"Metastatic disease","Immunotherapy","Liver metastasis","Mismatch-repair-proficient","Antibody targeting","Colorectal Cancer",{"date":38,"type":39},{"date":173,"type":39},"2025-03-12",{"date":175,"type":24},"2028-09-29",{"name":45,"class":46},76,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":19,"minAge":186,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":25,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},"100054149","phase-1-study-of-azd4512-monotherapy-or-in-combination-with-anticancer-agents-in-participants-with-acute-lymphoblastic-leukemia-100054149","NCT07109219","Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia","A Modular Phase I\u002FII, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AZD4512 Monotherapy or in Combination With Anticancer Agent(s) in Participants With Acute Lymphoblastic Leukemia","ALLight","Inclusion Criteria:\n\n* 1\\. Age:\n\n  * 16 years old in Module 1 (US only: ≥18year)\n  * 12 years old in Module 2\n\n    2\\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022).\n* Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \\> 5% or reappearance of blasts in PB)\n* Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R\u002FR\n* Backfill of Module 1 and Module 2 (DO): R\u002FR Ph(-) B-ALL\n\n  3\\. Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50)\n\n  4\\. Peripheral lymphoblast count \\\u003C 10,000\u002FµL (may receive cytoreduction prior to C1D1 per protocol-specified criteria)\n\n  5\\. At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available. Participants who have received prior CD22 targeted therapies are eligible.\n* Ph+ B-ALL (Module 1 DE only): intolerant to or have contraindications to TKI therapy or R\u002FR disease despite treatment with at least 2 prior TKIs or at least one 3rd generation TKI\n\n  6\\. Prior DLI \\>4 weeks, prior cell therapy or autoHSCT \\>8 weeks, alloHSCT \\>12 weeks\n\nExclusion Criteria:\n\n1. Burkitt lymphoma and leukemia\n2. Isolated extramedullary disease; Active testicular or CNS (\\> CNS1) involvement\n3. Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy)\n4. History of drug-induced non-infectious ILD\u002Fpneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n5. Prior\u002Fconcomitant therapy\n\n   * Cytotoxic treatment within 14 days (except ALL maintenance medications or cytoreduction)\n   * Biologic (immuno-oncology) treatment within 28 days or 5 half-lives (whichever is shorter)\n   * Non-CNS radiation within 2 weeks \\& CNS radiation within 4 weeks\n   * Medications known to prolong QTc and\u002For associated with Torsades de Pointes within 5 half-lives\n   * Strong inhibitors of CYP 3A4 within 14 days or 5 half-lives (whichever is longer)\n   * Investigational agents or study interventions in the last 30 days or 5 half-lives prior to the first dose of AZD4512 whichever is longer. If the investigational product is an agent to treat B-ALL and meets the modality criteria, then a specific washout period must be adhered to instead.","12 Years",{"count":188,"type":24},83,[27,28],"The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed\u002Frefractory B-Cell acute lymphoblastic leukemia (r\u002Fr B-ALL).",[192],"B-cell Acute Lymphoblastic Leukemia (B-ALL)",[194,195,196,197,198],"Acute lymphoblastic leukemia (B-ALL)","Dose escalation","Dose optimization","Cluster of differentiation 22 (CD22)","Antibody-drug conjugate (ADC)",{"date":38,"type":39},{"date":201,"type":39},"2025-11-12",{"date":203,"type":24},"2028-07-03",{"name":45,"class":46},26,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":25,"phases":217,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},"100054136","phase-3-long-term-safety-and-tolerability-of-tozorakimab-in-patients-with-copd-and-history-of-exacerbations-100054136","NCT07566195","Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations","A Phase III, Multicentre, Open-Label, Chronic Dosing, Extension Study to Evaluate the Long-term Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (ROMEO)","ROMEO","Inclusion Criteria:\n\n1. Participants previously randomized in predecessor studies.\n2. Participants should be affiliated with the French Social Security system.\n3. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor studies.\n4. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n1. Clinically important pulmonary disease other than COPD.\n2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.\n3. Current alcohol, drug or chemical abuse.\n4. Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO.\n5. Known history of:\n\n   1. Severe allergic reaction to any monoclonal and polyclonal antibody.\n   2. Allergy or reaction to any component of the IMP formulation.\n6. Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO.\n7. Receipt of live attenuated vaccines within 30 days prior to visit 1 of ROMEO.\n8. Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.\n9. Chronic use of antibiotics if the duration of treatment is \\\u003C 3 months prior to Visit 1 of ROMEO (first IMP administration). Chronic macrolide or other antibiotic therapy is allowed provided the participant has been on a stable dose\u002Fregimen for ≥ 3 months prior to Visit 1 of ROMEO (first IMP administration) and has had at least one COPD exacerbation while on stable therapy.\n10. Use of allergen immunotherapy within 3 months of Visit 1 of ROMEO (first IMP administration), except for stable maintenance dose allergen-specific immunotherapy started 4 weeks prior to V1.\n11. Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration).\n12. Participation in any interventional clinical trial or receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1 of ROMEO (first IMP administration), whichever is longer.\n13. Involvement in the planning and\u002For conduct of the study (applies to both staff employed by the Sponsor and\u002For staff at the study site).\n14. Participants who are not able to comply with the study requirements, procedures, and restrictions.","99 Years",{"count":216,"type":24},60,[218],"PHASE3","ROMEO is a Phase III, multicentre, open-label, chronic-dosing extension study evaluating the long-term safety of two dose regimens of tozorakimab in participants with COPD and a history of exacerbations.\n\nEligible participants must have completed one of the predecessor studies.",[221,222],"Chronic Obstructive Pulmonary Disease","COPD",[224,225,221,222,226,227,228,229],"Tozorakimab","MEDI3506","Exacerbations","Safety","Biologic","Biologic Treatment",{"date":38,"type":39},{"date":232,"type":39},"2026-05-05",{"date":234,"type":24},"2028-12-29",{"name":45,"class":46},13,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":25,"phases":246,"briefSummary":247,"conditions":248,"keywords":257,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":274},"100054097","phase-1-a-study-of-nt-175-in-adult-participants-with-advanced-malignancies-that-are-positive-for-hla-a0201-and-the-tp53-r175h-mutation-100054097","NCT05877599","A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicentre Platform Study to Evaluate the Safety and Preliminary Anti-tumour Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Participants With Advanced Malignancies That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria (Module 1)\n\n* Subjects must be at least 18 years of age\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria (Module 1)\n\n* Any another primary malignancy within the 3 years prior to enrollment\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.\n\nKey Inclusion Criteria (Module 2 - hematological malignancies)\n\n* At least 18 years of age\n* Diagnosis of AML or MDS that allows for efficacy assessments\n* Confirmation of TP53 R175H variant mutation in cancer cells\n* Subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* ECOG performance status of 0 to 1\n\nKey Exclusion Criteria (Module 2 - hematological malignancy)\n\n* Acute promyelocytic leukaemia or isolated extramedullary disease\n* Another primary malignancy within 2 years (with exceptions)\n* HSCT within 100 days or immunosuppression for GvHD within 4 weeks\n* History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells\n* Prior stroke, ischemic attack, significant cardiac disease, heart failure\n* Prior adoptive modified cell therapy\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.",{"count":245,"type":24},45,[27],"Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies",[249,250,251,252,253,254,255,256],"Non-small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Carcinoma","Pancreatic Adenocarcinoma","Breast Cancer","Other Solid Tumors","Ovarian Cancer","Myeloid Neoplasms (AML\u002FMDS)",[258,259,260,261,262,263,264,253,255,265,266,267],"Cell therapy","TP53","Solid tumors","Non-small cell lung cancer","Head and neck squamous cell carcinoma","Colorectal carcinoma","Pancreatic adenocarcinoma","AML","MDS","TCR",{"date":38,"type":39},{"date":270,"type":39},"2023-07-12",{"date":272,"type":24},"2029-07-31",{"name":45,"class":46},18,{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":283,"minAge":20,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":25,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100053940","phase-2-study-to-evaluate-the-safety-and-tolerability-of-camizestrant-in-combination-with-atirmociclib-in-women-with-advanced-breast-cancer-100053940","NCT07427394","Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer","A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)","SERENA-1b","Main Inclusion Criteria:\n\n* Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.\n* Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.\n* Eastern cooperative oncology group (ECOG)\u002FWorld Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.\n* At least one lesion that is measurable and\u002For non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.\n* Menopausal status\n\n  * Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.\n  * Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age \\\u003C60 years with ≥12 months amenorrhea and post-menopausal hormone levels.\n* Histological or cytological confirmation of adenocarcinoma of the breast.\n* Participants of childbearing potential must agree to use one highly effective contraceptive measure.\n* Documentation of ER-positive tumor irrespective of progesterone receptor status.\n\nMain Exclusion Criteria:\n\n* A participant who has received 2 or more lines of CDK4\u002F6 inhibitors in the advanced disease setting.\n* A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.\n* Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.\n* Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.\n* Inability to swallow oral medications.\n* Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).\n* Presence of life-threatening metastatic visceral disease.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Contraindication to or known intolerance\u002Fhypersensitivity of\u002Fto camizestrant or atirmociclib.","FEMALE",{"count":285,"type":24},24,[28],"A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor.",[289],"Advanced Breast Cancer",[291,292,293,294,295,296,227,297],"Estrogen receptor (ER)-positive","Human epidermal growth factor receptor 2 (HER2)-negative","Cyclin-Dependent Kinase (CDK) 4 inhibitors","Pharmacokinetics","Anti-tumor activity","Selective Estrogen Receptor Degrader (SERD)","Tolerability",{"date":38,"type":39},{"date":300,"type":39},"2026-05-06",{"date":302,"type":24},"2027-12-03",{"name":45,"class":46},6,{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":25,"phases":315,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":335},"100053964","phase-1-a-phase-i-dose-escalation-and-dose-expansion-study-to-investigate-the-pharmacokinetics-and-safety-of-subcutaneous-durvalumab-100053964","NCT07391670","A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab","A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants With Solid Tumours","IMFINZI-subQ","Inclusion Criteria:\n\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of ≥ 12 weeks at enrolment.\n* Adequate organ and marrow function.\n* Minimum body weight \\> 30 kg.\n\nPart 1 only:\n\nLocally Advanced Unresectable (Stage III) NSCLC Participants -\n\n* Histological or cytological documented evidence of NSCLC (locally advanced, unresectable, Stage III).\n* Must have received at least 2 cycles of platinum-based chemotherapy concurrent with definitive radiation therapy.\n* Have not progressed following definitive concurrent chemoradiation.\n\nLS-SCLC Participants -\n\n* Histologically or cytologically documented LS-SCLC (Stage I-III).\n* Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to enrolment.\n* Have not progressed following definitive concurrent chemoradiation.\n\nPart 1 and 2:\n\nUnresectable HCC Participants -\n\n* Unresectable HCC based on histopathological confirmation.\n* No prior systemic therapy for unresectable HCC.\n* Must not be eligible for locoregional therapy for unresectable HCC.\n* Child-Pugh Score class A.\n* Measurable disease as defined by RECIST v1.1.\n\nExclusion Criteria:\n\n* Active or prior documented autoimmune disease requiring systemic treatment.\n* Uncontrolled infection (including human immunodeficiency virus \\[HIV\\], hepatitis B or C).\n* Prior exposure to immune checkpoint inhibitors.\n\nPart 1 only:\n\nLocally Advanced Unresectable (Stage III) NSCLC Participants -\n\n* Mixed SCLC and NSCLC histology.\n* Active pneumonitis or interstitial lung disease requiring systemic therapy.\n\nLS SCLC Participants -\n\n* Mixed SCLC and NSCLC histology.\n* Extensive-stage disease.\n* History of Grade ≥ 2 pneumonitis.\n\nPart 1 and 2:\n\nUnresectable HCC Participants -\n\n* Hepatic encephalopathy.\n* Uncontrolled ascites.\n* Active gastrointestinal (GI) bleeding.",{"count":314,"type":24},40,[27],"The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).",[318],"Solid Tumours",[294,320,321,322,323,324,325,326,327,328],"Non-small cell lung cancer (Stage III, unresectable)","Small cell lung cancer (Limited stage)","Hepatocellular carcinoma (Unresectable)","Subcutaneous","Human hyaluronidase","Monoclonal antibody","Programmed cell death ligand 1 (PD-L1)","Programmed cell death protein 1","Anticancer therapy",{"date":38,"type":39},{"date":331,"type":39},"2026-03-31",{"date":333,"type":24},"2027-08-30",{"name":45,"class":46},19,{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":25,"phases":345,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":47},"100053571","phase-1-azd0305-as-monotherapy-or-in-combination-with-anticancer-agents-in-participants-with-multiple-myeloma-100053571","NCT06106945","AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma","A Modular Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Multiple Myeloma","Key Inclusion Criteria:\n\n* Participants must be at least 18 years of age or the legal age of consent in the jurisdiction\n* in which the study is taking place;\n* Eastern Cooperative Oncology Group performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3;\n* Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria;\n* Participants must have one or more measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;\n* Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module;\n* Participants must have received at least 3 prior lines of treatment in module 1, or 1-3 prior lines in modules 2 and 3, with additional module-specific requirements related to prior lines of therapy\n\nThe above is a summary of key criteria, other inclusion criteria details may apply\n\nKey Exclusion Criteria:\n\n* Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);\n* Participants exhibiting clinical signs of central nervous system involvement of MM;\n* Participants with known COPD, or previous history of ILD\u002Fpneumonitis;\n* Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification;\n* Participants who have severe cardiovascular disease which is not adequately controlled;\n* Participants who have a history of immunodeficiency disease;\n* Participants with peripheral neuropathy ≥ Grade 2;\n* Primary refractory MM;\n* Participants who have previously received anti-GPRC5D or MMAE-containing treatment;\n* Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention;\n* Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply;\n* Participants with previous history of active JC virus infection resulting in PML;\n* Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monoclonal antibody therapy;\n* Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and\u002For other administration\n\nThe above is a summary of key criteria, other exclusion criteria details may apply",{"count":344,"type":24},226,[27,28],"This is a Phase I\u002FII, modular, open-label, multicenter, dose escalation, and dose expansion\u002Foptimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics and efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.",[348],"Multiple Myeloma",[350,351,352,348,353,354],"GPRC5D","ADC","AZD0305","MM","MMAE",{"date":38,"type":39},{"date":357,"type":39},"2023-12-05",{"date":359,"type":24},"2027-08-16",{"name":45,"class":46},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":122},"100053459","a-multi-centre-chart-review-study-of-stage-i-iii-non-small-cell-lung-cancer-in-china-100053459","NCT07316062","A Multi-centre Chart Review Study of Stage I-III Non-Small Cell Lung Cancer in China","A Multi-centre Chart Review Study on the Treatment Patterns and Outcomes of Stage I-III Non-Small Cell Lung Cancer in China","MAP","Inclusion Criteria:\n\n* Stage I-III at initial NSCLC diagnosis\n* Aged ≥18 years at first diagnosis of NSCLC\n* Timeframe of NSCLC diagnosis:\n\nFor DE1: diagnosed with NSCLC during the period between May 1st 2025 and December 31st 2025 For DE2: diagnosed with NSCLC during the period between May 1st 2026 and December 31st 2026 For DE3: diagnosed with NSCLC during the period between May 1st 2027 and December 31st 2027\n\nExclusion Criteria:\n\n* NSCLC is not the primary cancer diagnosis\n* Patients with a recent history of other tumor or concurrent other tumor\n* Patients participating in interventional clinical trials at time of initial diagnosis\n* Patients with positive pregnancy status at the time of diagnosis",{"count":370,"type":24},3000,"This chart review study is proposed in China to understand the treatment patterns, biomarker testing, and clinical outcomes with SOC and some selected regimens among patients diagnosed with stage I-III NSCLC.",[373],"Non-Small-Cell Lung",[375],"NSCLC, chart review",{"date":38,"type":39},{"date":378,"type":39},"2026-04-29",{"date":380,"type":24},"2029-04-30",{"name":45,"class":46},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":392,"conditions":393,"keywords":395,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":403},"100053349","study-for-assessing-the-prevalence-of-airflow-limitation-in-outpatients-with-history-of-smoking-attending-cardiology-clinics-100053349","NCT07315958","Study for Assessing the Prevalence of Airflow Limitation in Outpatients With History of Smoking Attending Cardiology Clinics","A Multinational, Multicenter, Observational, Prospective Cohort Study for Assessing the Prevalence of Airflow Limitation in Outpatients With History of Smoking Attending Cardiology Clinics","ALSAC","Inclusion Criteria:\n\n1. Patients aged 40 years or older.\n2. Patients with a smoking history of 10 pack-years or more.\n3. Patients willing and able to complete pulmonary function test, using a spirometer.\n4. Patients who have provided written consent to participate in the study.\n5. Patients attending cardiology clinics at the participating centers.\n6. Patients willing and able to complete the CAAT questionnaire.\n\nExclusion Criteria:\n\nA. Patients diagnosed with bronchial asthma. B. Patients who used a bronchodilator for an acute respiratory infection before performing spirometry.",{"count":391,"type":24},1000,"Chronic Obstructive Pulmonary Disease (COPD) is a global health concern, associated with structural lung abnormalities causing persistent airflow limitation (AL) and often result from cigarette smoking. In Turkey, COPD was ranked the third among the mortality causes and the eighth among disability causes, with 9.1% to 19.1% prevalence rate. In the Middle East and North Africa (MENA) region, an increase of 30.6% in age-standardized point prevalence occurred between 1990 and 2019, with an estimated 10.7 million COPD cases. Similarly, in the sub-Saharan Africa region, the highest COPD prevalence rate of 24.8% was observed in South Africa. And in Kenya, East Africa, the pooled point estimate prevalence of COPD was 11.3%. The prevalence of COPD varies substantially between countries, but comparing numbers is challenging because they are recorded in different units and during different periods.\n\nPatients with COPD are more likely to develop cardiovascular disease (CVD). For instance, COPD has been shown to increase the risk of acute myocardial infarction by 40% and stroke by 50%. Likewise, COPD patients with CVD have a considerably higher risk of COPD exacerbations than those without CVD. COPD and CVD have been linked to a worse prognosis primarily related to increased systemic inflammation; the presence of a concomitant disease with COPD leads to reduced quality of life, increased hospitalizations, and worse survival. For instance, every increase of 70 cL\u002Fs in forced expiratory volume in 1 second (FEV1) reduces mortality risk by 28%-35% from cardiovascular disease and 68%-72% from respiratory disease. Besides that, smoking has been shown to increase the risk of myocardial infarction (MI) and heart failure (HF) twofold, cigarette smoking toxins promote inflammation systemically, which may result in emphysema and atherosclerosis. Nevertheless, chronic inhalation of irritants, including biomass fuel smoke and air pollutants, produces an innate immune response and a later activation of adaptive immunity that might further amplify inflammation. Similarly, age-related elastin degradation may increase the risk of emphysema and arterial hypertension. On the contrary, physical activity is associated with improved lung function and a lower resting heart rate (RHR); consequently, COPD and CVD are more prevalent in sedentary populations. Observational studies suggest that decreasing the progression of COPD may assist in preventing cardiovascular morbidity and mortality, which is related to more severe respiratory symptoms.",[394],"Respiratory (Chronic Obstructive Pulmonary Disease)",[396],"chronic obstructive pulmonary disease",{"date":38,"type":39},{"date":399,"type":39},"2025-10-08",{"date":401,"type":24},"2026-09-30",{"name":45,"class":46},2,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":25,"phases":412,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":236},"100053228","phase-1-a-phase-i-open-label-multicenter-study-to-evaluate-the-safety-tolerability-cellular-kinetics-immunogenicity-pharmacodynamics-and-preliminary-efficacy-of-azd0120-in-participants-with-multiple-myeloma-durga-2-100053228","NCT07073547","A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants With Multiple Myeloma (DURGA-2)","A Modular, Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120, a Dual-targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19 in Participants With Multiple Myeloma (DURGA-2)","Inclusion Criteria:\n\nAge:\n\n* Males and females ≥18 years of age at the time of consent\n\nType of Participant and Disease Characteristics:\n\n* Participant must have documented diagnosis of MM per IMWG diagnostic criteria\n* ECOG performance status of 0 or 1.\n* Adequate organ and bone marrow function.\n\nFor NDMM participants:\n\n* Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable)\n* For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of 6 cycles of induction therapy completed prior to screening\n* Classified as high-risk MM\n\nFor Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:\n\n* Have received and failed 1 or 2 lines of anti-myeloma therapy\n* Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy\n* Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen\n\nGeneral Exclusion Criteria:\n\n* Have received prior treatment with CAR T therapy directed at any target\n* Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma\n* Active or history of plasma cell leukemia at the time of screening\n* Seropositive for human immunodeficiency virus (HIV)\n* Active Hepatitis B infection\n* Active Hepatitis C infection\n* Serious underlying medical condition",{"count":314,"type":24},[27],"This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).",[348],[416,417,418,419],"Multiple myeloma","BCMA","CD19","CAR-T",{"date":38,"type":39},{"date":422,"type":39},"2025-07-31",{"date":424,"type":24},"2028-05-26",{"name":45,"class":46},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":25,"phases":436,"briefSummary":437,"conditions":438,"keywords":441,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":304},"100053223","phase-1-a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd4954-in-healthy-adult-participants-with-or-without-elevated-lipoprotein-a-lpa-levels-and-participants-with-dyslipidemia-100053223","NCT06980428","A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia","A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4954 Following Single and Multiple Ascending Dose Administration to Healthy Participants With or Without Elevated Lp(a) Levels, and Participants With Dyslipidemia","Inclusion Criteria:\n\nAll Parts:\n\n* Participants with plasminogen level (concentration) within normal range at the Screening Visit.\n* All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.\n* Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.\n* Females of non-childbearing potential must be confirmed at the Screening Visit.\n* Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention until 3 months after the study Follow-up Visit.\n\nParts A and B (Healthy Participants):\n\n* Male and female participants aged 18 to 65 years with suitable veins for cannulation or repeated venipuncture.\n* Have a body mass index (BMI) between 18 and 35 kg\u002Fm² inclusive.\n* For Japanese and Chinese participants (Parts A and B):\n\n  1. A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan.\n  2. A Chinese participant is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.\n\n     Part B (Healthy Participants):\n* Participants must have elevated Lp(a) ≥ 30 mg\u002FdL at the Screening Visit.\n\nPart B (Participants with Dyslipidemia):\n\n* Male and female participants aged 18 to 70 years with suitable veins for cannulation or repeated venipuncture.\n* Have a BMI \\> 18 kg\u002Fm².\n* Participants must have elevated Lp(a) ≥ 70 mg\u002FdL at the Screening Visit.\n* Participants with a fasting LDL-C ≥ 70 mg\u002FdL and \\\u003C 190 mg\u002FL at the Screening Visit.\n* Participants should be receiving moderate or high-intensity statin therapy for ≥ 2 months prior to the Screening Visit, according to the American College of Cardiology\u002FAmerican Heart Association guidelines on blood cholesterol management.\n* Participants with documented coronary artery disease, stroke, or peripheral artery disease or at moderate or high risk for an atherosclerotic cardiovascular disease event.\n* There should be no planned medication or dose change during study participation.\n\nExclusion Criteria:\n\nAll Parts:\n\n* History of any clinically important disease or disorder.\n* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically important illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n* Participants with known bleeding or coagulation disorders.\n* Participants who have an elevated high-sensitivity C-reactive protein (\\> 3 mg\u002FL) or have a prothrombin time\u002Finternational normalized ratio (PT\u002FINR) or activated partial thromboplastin time (aPTT) \\> 1.25 times × upper limit normal (ULN).\n* Any clinically important abnormalities in hematology, coagulation, clinical chemistry, urinalysis, abnormal vital signs or abnormal laboratory values.\n* Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).\n* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.\n* Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.\n\nParts A and B (Healthy Participants):\n\n* Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol\u002Facetaminophen), herbal remedies, intake of \\> 3 × daily recommended levels of vitamins and minerals during the 2 weeks prior to the first administration of study intervention or longer if the medication has a long half-life.\n* Current smokers or those who have smoked or used nicotine products.\n\nPart B (Participants with Dyslipidemia):\n\n* Acute ischemic cardiovascular event in the last 12 months prior to randomization.\n* Poorly controlled diabetes.\n* Previous administration of Lp(a) inhibitor.\n* Have uncontrolled hypertension.\n* Abnormal vital heart rate.","70 Years",{"count":435,"type":24},136,[27],"The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp\\[a\\]) levels and participants with dyslipidemia.",[439,440],"Healthy Participants","Dyslipidemia",[442,443],"Lipoprotein(a)","Low-density lipoprotein cholesterol (LDL-C)",{"date":38,"type":39},{"date":446,"type":39},"2025-05-27",{"date":448,"type":24},"2026-12-04",{"name":45,"class":46},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":457,"targetDuration":458,"studyType":110,"phases":4,"briefSummary":459,"conditions":460,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":122},"100629965","a-prospecitve-multicenter-observational-registry-study-100629965","NCT07481526","A Prospecitve Multicenter, Observational Registry Study","A Multicenter Real-World Registry of Characteristics, Treatment Strategies, and Clinical Outcomes in Chinese Adults With Chronic Kidney Disease","Inclusion Criteria:\n\n* Male or female patients aged ≥18 years.\n* Willing and able to provide written informed consent to participate in the study.\n* Confirmed CKD diagnosis at enrolment, defined by at least one of the following:\n\n  * eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² for ≥3 months, OR\n  * Evidence of kidney damage (e.g., UACR ≥30 mg\u002Fg or UPCR ≥150 mg\u002Fg, structural abnormality on imaging, or kidney biopsy findings consistent with chronic kidney injury) persisting for ≥3 months\n\nExclusion Criteria:\n\n* Having a life-threatening comorbidity with life expectancy \\\u003C 2 years.\n* Severe cardiac disease: life-threatening arrhythmias, or recent MACE (Myocardial infarction (MI), stroke, CV death) within the past 3 months.\n* Pregnant or breastfeeding women.\n* Currently enrolled in any interventional clinical trial or receiving investigational therapy within 3 months of enrollment.\n* Presenting with ESRD, RRT, acute kidney injury (AKI), acute kidney disease (i.e., kidney injury or a decline in renal function persisting for ≤3 months) as a primary disease condition at enrollment.",{"count":370,"type":24},"96 Weeks","This is a prospective, multicenter, observational registry study designed to collect data to deepen the understanding of CKD therapeutics, changes in clinical practice, cardiorenal risk outcomes and differences in treatment approaches in Chinese CKD patients.",[461],"Chronic Kidney Disease","2026-07-01",{"date":464,"type":39},"2026-07-02",{"date":466,"type":39},"2026-02-27",{"date":468,"type":24},"2028-12-30",{"name":45,"class":46},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":477,"enrollmentInfo":478,"targetDuration":4,"studyType":25,"phases":480,"briefSummary":481,"conditions":482,"keywords":484,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":403},"100619387","phase-1-a-phase-i-study-to-investigate-the-pharmacokinetics-and-safety-of-capivasertib-in-participants-with-moderate-hepatic-impairment-100619387","NCT07343960","A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment","A Phase I, Single-dose, Non-randomized, Open-label, Parallel Group Study to Assess the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment","Key Inclusion Criteria:\n\n* Body weight of at least 50 kg and Body Mass Index (BMI) of between ≥ 18 up to ≤ 40 kg\u002Fm2.\n* Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Participants must have suitable veins for cannulation or repeated venipuncture.\n* Non-smoker, defined as a participant who has not smoked previously or who has discontinued smoking or the use of other nicotine\u002Fnicotine-containing products at least 3 months before the Screening Visit.\n* Supporting documents confirming the participant's hepatic impairment must be available (a liver biopsy is preferable but not mandatory); participants must be classified by the Investigator as Child Pugh class B.\n* Participants must meet National Cancer Institute - Organ Dysfunction Working Group (NCI-ODWG) classification of total bilirubin 1.5 to 3\\*upper limit of normal (ULN) and any Aspartate aminotransferase\u002Ftransaminase (AST) for moderate hepatic impairment.\n* Stable hepatic impairment\n* For participants with normal hepatic function, Bilirubin \\\u003C 1.5 × ULN, alanine aminotransferase (ALT), AST, albumin, alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) \\\u003C 1.2 × ULN. Creatinine \\\u003C ULN. White blood cell count \\> lower limit of normal (LLN).\n\nKey Exclusion Criteria:\n\n* Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, significant aneurysm, renal transplant and active bleeding diseases) which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.\n* Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of capivasertib.\n* History of primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.\n* Active tuberculosis infection.\n* Known Human Immunodeficiency Virus (HIV) infection, active hepatitis B or C infection, positive hepatitis C antibody, and\u002For positive hepatitis B virus surface antigen.\n* Clinically significant abnormalities of glucose metabolism as defined by HemoglobinA1c (HbA1c) ≥ 8.0% (63.9 mmol\u002Fmol) at screening.\n* Moderate or severe renal dysfunction according to age-related creatinine clearance estimated using CKD-EPI formula (i.e., creatinine clearance less than 60 mL\u002Fmin).\n* Fluctuating or rapidly deteriorating hepatic function.\n* Presence of a hepatocellular carcinoma or acute liver disease caused by an infection or drug toxicity.\n* Severe portal hypertension or surgical porto-systemic shunts.\n* Biliary obstruction or other causes of hepatic impairment not related to parenchymal disorder and\u002For disease of the liver.\n* Clinically relevant hepatic encephalopathy (Grade 3 or more).\n* Severe ascites.\n* Esophageal variceal bleeding (unless banded) within the past 2 months.\n* Post-liver transplantation.","80 Years",{"count":479,"type":24},20,[27],"The purpose of this study is to measure the pharmacokinetics (PK), safety, and tolerability of capivasertib in participants with moderate hepatic impairment and participants with normal hepatic function (as control).",[483],"Moderate Hepatic Impairment",[485,486,487,488,489,294],"Hepatic function","Anti-cancer agent","Pyrrolopyrimidine-derived compound","Liver metabolism","Serine\u002Fthreonine protein kinase AKT",{"date":464,"type":39},{"date":492,"type":39},"2026-01-06",{"date":494,"type":24},"2026-11-11",{"name":45,"class":46},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":25,"phases":507,"briefSummary":508,"conditions":509,"keywords":512,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":523},"100608438","phase-1-study-evaluating-safety-tolerability-pkpd-of-surovatamig-in-adult-ra-or-sle-participants-100608438","NCT07201558","Study Evaluating Safety, Tolerability, PK\u002FPD of Surovatamig in Adult RA or SLE Participants","An Open-label, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus","ASSURO","Inclusion Criteria:\n\n1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive, at the time of signing the informed consent.\n2. For RA participants, only:\n\n\u003C!-- -->\n\n1. Diagnosis of RA as defined by the 2010 EULAR\u002FACR classification criteria\n2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory.\n\n   (a) RF (b) ACPA\n3. Moderate or severe disease activity defined as:\n\nDAS28-CRP \\> 3.2 AND\n\n* 4 tender joints and ≥ 4 swollen joints\n\n  (a) US-Specific Criterion: DAS28-CRP \\> 3.2 AND ≥ 6 tender joints and ≥ 6 swollen joints 4. Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b\u002FtsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.\n\n  5\\. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12:\n\n  (a) Oral prednisone (or equivalent). Dose must be stable and ≤ 10mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (e.g. hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following csDMARDs for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg per week, without change of route of administration for 8 weeks prior to Day 1 (ii) Sulfasalazine ≤ 3g\u002Fday (iii) Leflunomide ≤ 20 mg\u002Fday 3. For SLE participants, only:\n  1. Diagnosis of SLE as defined by the 2019 EULAR\u002FACR classification criteria\n  2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory. If autoantibodies are negative on central laboratory test, documented history of test results may be used. (a) ANA immunofluorescent assay test (titer ≥ 1:80) (a) Anti-dsDNA (b) Anti-Sm.\n  3. Moderate or severe disease activity defined as clinical SLEDAI-2K \\> 4\n\n     (a) US-specific criterion: clinical SLEDAI-2K ≥ 6\n  4. Intolerance to or inadequate response following approximately 3 months treatment or longer ≥ 3 SoC (includes: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies). There is no minimum duration for taking a treatment in cases of intolerance.\n  5. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12: (a) Oral prednisone (or equivalent. Dose must be stable and ≤ 20mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (eg, hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following immunosuppressive treatments. for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg\u002Fweek, without change of route of administration for 8 weeks prior to Day 1 (ii) Mycophenolate mofetil or equivalent ≤ 2 g\u002Fday (dose must be ≤ 2 g\u002Fday for 3 months prior to Day 1) (iii) Azathioprine ≤ 200 mg\u002Fday (iv) Leflunomide ≤ 20 mg\u002Fday (v) Tacrolimus ≤ 0.1 mg\u002Fkg\u002Fday with maximum dose of 5 mg\u002Fday (vi) Cyclosporin ≤ 3 mg\u002Fkg\u002Fday with maximum dose of 200 mg\u002Fday\n\n  4\\. Blood B cells ≥ 50 cells\u002FμL at screening. 5. IgG levels ≥ 6 g\u002FL at screening. 6. Eligibility for re-treatment of previously treated participants only. The following criterion applies only to participants being considered for re-treatment and is not applicable to participants undergoing initial screening for study entry.\n\n  1\\. Participants treated in prior study cohorts who did not experience an IMP-related DLT or discontinue treatment and\u002For participation due to an IMP-related AE are eligible for re-treatment in Parts 2 and 3. Participants must otherwise meet all protocol-defined eligibility criteria, with the exception of Inclusion Criterion 17 (B cell count), and meet one of the 2 criteria below:\n  1. Completed the 6-month treatment period OR\n  2. Completed a minimum of 90 days in the treatment period and have peripheral B cell counts that are ≥ 90% of baseline or above lower limit of normal (LLN)\n\n     Exclusion Criteria:\n     1. Any complications of disease under study that are judged by the Investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to: (a) Active severe SLE-driven renal disease. (b) Severe lung or cardiac involvement. (c) History of, or current diagnosis of, catastrophic or severe APS (eg, diagnosis of an arterial or central\u002Fpulmonary venous clot) within 1 year prior to signing the ICF. Participants with clinically evident APS which is adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited into the study. (d) Rapidly progressive and\u002For severe ILD or ILD that requires oxygen supplementation\u002Ftherapy (of any type). (e) Felty's syndrome\n     2. History of HLH\u002FMAS.\n     3. For RA participants, only:\n\n     \u003C!-- -->\n\n     1. Juvenile idiopathic arthritis or idiopathic arthritis diagnosed before the age of 16.\n     2. Axial spondylarthritis or any other disease associated with inflammatory arthritis\n\n     4\\. For SLE participants, only:\n\n     1.History of active, severe or unstable neuropsychiatric SLE, except for headache and peripheral neuropathies. 5. Other active or prior documented severe, complex, autoimmune or inflammatory disorders. Exceptions to this exclusion criteria include: (a) Vitiligo or alopecia (b) Hypothyroidism stable on hormone replacement (c) Controlled type I diabetes mellitus on insulin (d) Any chronic skin condition that does not require systemic immunosuppressant or biologic therapy (e) Celiac disease, controlled by diet alone (f) Participants with secondary Sjögren's disease are eligible provided that immunosuppression is primarily prescribed for the disease under study (ie, SLE or RA) and not for secondary Sjögren's. 6. Significant CNS co-morbidity (eg, Parkinson's, stroke, CNS vasculitis, severe brain injury, dementia, neurodegenerative diseases, cerebellar disease, epilepsy\u002Fseizure disorders, PML, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases).\n\n     7\\. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.\n\n     8\\. Exclusion Criteria Related to Infection:\n\n     1\\. Any clinical suspicion or diagnosis of active infection at screening. 2. Opportunistic infection that meets criteria to be an SAE within 3 years. 3. Clinically significant chronic infection (for example osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections which are not exclusionary) 4. Any infection requiring hospitalisation or treatment with IV anti-infectives with treatment completed less than 4 weeks prior to signing the ICF.\n\n     5\\. Any infection requiring oral anti-infectives within 2 weeks prior to signing the ICF.\n\n     6\\. History of recurrent infection requiring hospitalisation or IV antibiotics (eg, 3 or more of the same type of infection, including systemic fungal infections, over the previous 52 weeks).\n\n     9\\. Participants who, as judged by the Investigator, have evidence of active TB, or latent TB or have a household contact with known diagnosis of current active TB.\n\n  \u003C!-- -->\n\n  1. TB evaluation will be performed according to the local SoC as determined by local guidelines and may include history and physical examinations, chest X-ray, or TB test (eg, purified protein derivative or QuantiFERON® test).\n  2. Participants with a prior diagnosis of active or latent TB who have documented evidence they have completed a full course of appropriate treatment are not excluded.\n\n     However, a previous history of multidrug-resistant or extensively drug-resistant TB is exclusionary regardless of treatment status. 10. Participant with human immunodeficiency virus infection (confirmed by central laboratory at screening) 11. Participant with active EBV or CMV, assessed clinically. 12. Participant with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive (tested at screening visit).\n\n     13\\. Participant with evidence of chronic or active Hepatitis C, meeting any of the criteria below: (a) HCV RNA positive or detectible at screening (b) HCV antibody positive at screening (apart from those with negative HCV RNA \\>12 weeks after completion of curative antiviral treatment for HCV or those with sustained negative HCV RNA 12 weeks apart following resolution of HCV infection if not treated).\n\n     14\\. Participant positive with COVID-19 PCR at screening. If patients test positive at screening or Day 1 but meet other eligibility criteria, they may be re-tested after ≥ 2 weeks. If this falls within the screening window, then they do not require re-screening.\n\n     15\\. Receipt of any of the following treatments or interventions ever: (a) TCEs, with the exception of surovatamig under the conditions specified in Inclusion Criterion 19 (b) Bone marrow transplant (c) Stem cell transplant (d) Total lymphoid irradiation (e) CAR-T cell therapy (f) Alemtuzumab 16. For females only - currently pregnant (confirmed with positive pregnancy test), planning to become pregnant within the study period, or breast feeding.","65 Years",{"count":506,"type":24},48,[27],"This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.",[510,511],"Rheumatoid Arthritis","Systemic Lupus Erythematosus",[513,514,515,516],"adult participants","rheumatoid arthritis","systemic lupus erythematosus","surovatamig",{"date":464,"type":39},{"date":519,"type":39},"2025-12-02",{"date":521,"type":24},"2028-06-27",{"name":45,"class":46},33,{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":19,"minAge":532,"maxAge":477,"enrollmentInfo":533,"targetDuration":4,"studyType":25,"phases":535,"briefSummary":537,"conditions":538,"keywords":540,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":551},"100598627","phase-4-a-study-to-investigate-the-effect-of-budesonideglycopyrroniumformoterol-fumarate-metered-dose-inhaler-bgf-mdi-compared-with-placebo-mdi-on-heart-and-lung-function-in-participants-with-chronic-obstructive-pulmonary-disease-copd-and-hyperinflation-100598627","NCT07073950","A Study to Investigate the Effect of Budesonide\u002FGlycopyrronium\u002FFormoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation","A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide\u002FGlycopyrronium\u002FFormoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation","ORATOS","Key Inclusion Criteria:\n\n* Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.\n* A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second\u002Fforced vital capacity (FEV1\u002FFVC) \\\u003C 0.7.\n* At Visit 1: A pre-bronchodilator FEV1 \\\u003C 80%.\n* At Visit 1: Peripheral blood eosinophil count \\\u003C 300 cells\u002Fcubic millimeter (mm³), with no recorded history of eosinophil count \\> 300 cells\u002Fmm³ in the past 12 months.\n* At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.\n* At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of \\> 135% of predicted normal FRC.\n* At Visit 2: A post-bronchodilator FEV1 ≥ 30% and \\\u003C 80% of the predicted normal value.\n* Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.\n* Female participants must either be not of childbearing potential or using a form of highly effective birth control.\n* All women of child bearing potential must have a negative pregnancy test at the Visit 1.\n\nExclusion Criteria:\n\n* A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.\n* History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.\n* History of myocardial infarction or acute coronary syndrome.\n* History or current clinically significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).\n* Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.\n* Participants with ECG QTcF interval at Visit 1 \\> 460 milliseconds (ms) for males and \\> 480 ms for females.\n* Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and\u002For during the screening\u002Frun-in period.\n* Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.","40 Years",{"count":534,"type":24},56,[536],"PHASE4","The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.",[221,539],"Hyperinflation",[541,542,543,544],"Metered Dose Inhalers (MDI)","Inhaled Corticosteroid (ICS)","Long-acting muscarinic antagonist (LAMA)","Long-acting beta2 agonist (LABA)",{"date":464,"type":39},{"date":547,"type":39},"2025-11-24",{"date":549,"type":24},"2027-05-31",{"name":45,"class":46},7,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":19,"minAge":186,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":25,"phases":562,"briefSummary":563,"conditions":564,"keywords":566,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":574},"100599779","phase-2-a-study-to-evaluate-the-efficacy-safety-and-pk-of-azd0292-administered-iv-in-participants-12-years-of-age-and-older-with-bronchiectasis-and-chronic-pseudomonas-aeruginosa-colonization-100599779","NCT07088926","A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","CLEAR","Inclusion Criteria:\n\n1. Participant must be ≥ 12 years of age at the time of signing the informed consent\u002Fassent\n2. Weight ≥ 35 kg\n3. Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.\n4. Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics\n5. Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization\n6. Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.\n7. Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening\n8. Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.\n9. Capable of giving signed informed consent\u002Fassent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n\nExclusion Criteria:\n\n1. Primary lung diagnosis other than bronchiectasis\n2. Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy\n3. Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment\n4. Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed\n5. Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment\n6. AIDS or Advanced human immunodeficiency virus disease (CD4 count of \\\u003C 200 cells\u002Fmm3)\n7. History of severe adverse reaction associated with a mAb, and\u002For history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine\u002Fadrenaline or hospitalization), and\u002For history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration\n8. Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening\n9. Chronic immunosuppressive therapy (including prednisolone \\> 5 mg or equivalent) newly initiated within the last 3 months\n10. Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study\n11. Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening\n12. Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration",{"count":561,"type":24},435,[28],"AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.",[565],"Bronchiectasis With Pseudomonas Aeruginosa Colonization",[567],"Bronchiectasis Chronic Pseudomonas Aeruginosa Colonization",{"date":464,"type":39},{"date":570,"type":39},"2025-11-06",{"date":572,"type":24},"2028-06-14",{"name":45,"class":46},185,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":157,"enrollmentInfo":583,"targetDuration":4,"studyType":25,"phases":584,"briefSummary":585,"conditions":586,"keywords":589,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":598},"100594842","phase-2-phase-2-study-of-disease-risk-mutation-guided-finite-acalabrutinibvenetoclax-for-relapsed-cll-post-1l-finite-cbtkibcl2i--obinutuzumab-100594842","NCT07024706","Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab","The MAVRiC Study: A Phase II Study of Disease Risk Mutation Guided Finite Duration Acalabrutinib Plus Venetoclax for Relapse in CLL\u002FSLL After First-line Finite Covalent BTKi Plus BCL2i Combination, With or Without Obinutuzumab","MAVRiC","Main Inclusion Criteria:\n\n1. Participant must be ≥ 18 years at the time of signing informed consent.\n2. Diagnosis of CLL\u002FSLL according to iwCLL guidelines 2018 (Hallek et al. 2018)\n3. Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ PR (i.e., CR, CRi, nPR, or PR) with a minimum of 2 years since the end of the prior 1L treatment.\n4. The following data must be available or at least the appropriate samples drawn\u002Facquired prior to dosing:\n\n   1. IGHV (mutated vs. unmutated)\n   2. del(17p) (present or absent)\n   3. TP53 mutation (present or absent)\n5. ECOG performance status 0, 1 or 2\n6. Adequate organ and bone marrow (BM) function.\n\nMain Exclusion Criteria:\n\n1. Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study.\n2. Significant cardiovascular or cerebrovascular disease.\n3. Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).\n4. Child-Pugh B\u002FC liver cirrhosis.\n5. History of prior or current malignancy.\n6. HIV positive\n7. History of progressive multifocal leukoencephalopathy (PML).\n8. Active hepatitis B or C infection:\n9. Corticosteroid use \\> 20 mg within 1 week before the first dose of study intervention.\n10. History of hypersensitivity or anaphylaxis to study intervention(s).\n11. Requires treatment with a strong CYP3A4 inhibitor\u002Finducer.\n12. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.\n13. Major surgical procedure within 30 days of the first dose of study intervention.",{"count":159,"type":24},[28],"This study will evaluate the efficacy and safety of finite-duration acalabrutinib plus venetoclax therapy in patients with relapsed CLL or SLL, and have previously responded to first line (1L) cBTKi + BCL2i therapy (± obinutuzumab) and maintained a response for at least two years post-treatment.",[587,588],"Chronic Lymphocytic Leukemia (CLL)","Small Lymphocytic Lymphoma (SLL)",[587,588,590,591,139],"Relapsed CLL","Refractory CLL",{"date":464,"type":39},{"date":594,"type":39},"2026-06-04",{"date":596,"type":24},"2033-03-23",{"name":45,"class":46},36,{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":25,"phases":609,"briefSummary":610,"conditions":611,"keywords":613,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":621},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":608,"type":24},15100,[218],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[612],"Cardiovascular Disease",[614],"Atherosclerotic Cardiovascular Disease",{"date":464,"type":39},{"date":617,"type":39},"2025-06-04",{"date":619,"type":24},"2029-10-26",{"name":45,"class":46},1365,{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":630,"enrollmentInfo":631,"targetDuration":4,"studyType":25,"phases":632,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":643},"100636904","phase-2-a-study-to-assess-the-effect-of-surovatamig-in-adult-participants-with-antibody-mediated-kidney-disease-100636904","NCT07571746","A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease","A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease","CLEAR-AbKD","Inclusion Criteria:\n\n1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age inclusive, at the time of signing the informed consent.\n2. Diagnosis of anti-PLA2R antibody-positive pMN.\n3. All participants must have received SoC therapy with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for ≥ 4 weeks, with exceptions in case of intolerance, contraindications, or low blood pressure, before the screening period.\n4. Positive for anti-PLA2R.\n5. Up to date with required vaccinations as per institutional guidelines (eg, influenza, pneumococcal, and severe acute respiratory syndrome coronavirus 2) prior to study entry.\n6. Male and\u002For female assigned at birth, inclusive of all gender identities. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n7. Capable of giving signed informed consent\n\nExclusion Criteria:\n\n1. Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies \\\u003C 9 months before screening.\n2. Immunomodulatory therapy \\\u003C3 months before screening.\n3. Secondary causes of membranous nephropathy\n4. Diabetes mellitus with haemoglobin A1C \\> 8.5% tested at screening visit.\n5. Malignancies\n6. History of HLH\u002FMAS. 7 Significant CNS co-morbidity\n\n8\\. History of chronic significant respiratory disease. 9. Significant opportunistic infection in the medical history deemed relevant by the Investigator.\n\n10\\. Abnormal vital sign after 10 minutes sitting at rest. 11. Administration of corticosteroids such as prednisolone at doses exceeding 20 mg or an equivalent agent \\\u003C 2 months before screening.","75 Years",{"count":47,"type":24},[28],"The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous injection in adult participants with primary membranous nephropathy.",[635],"Primary Membranous Nephropathy","2026-06-30",{"date":462,"type":39},{"date":639,"type":39},"2026-03-28",{"date":641,"type":24},"2029-10-15",{"name":45,"class":46},22,{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":56,"minAge":20,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":25,"phases":654,"briefSummary":655,"conditions":656,"keywords":658,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":660,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":666},"100637445","phase-3-azd2265-compared-with-standard-of-care-in-psma-positive-metastatic-castration-resistant-prostate-cancer-vectra-01-100637445","NCT07611110","AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","VECTRA-01","Inclusion Criteria:\n\n* ≥ 18 years of age.\n* Diagnosis of adenocarcinoma of prostate.\n* Must have had prior orchiectomy and\u002For ongoing ADT and a castrate level of plasma\u002Fserum testosterone.\n* Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and\u002For non-measurable) that is suitable for repeated assessment by CT and\u002For MRI and\u002For bone scan.\n* Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.\n* Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC.\n* Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).\n* Positive PSMA PET\u002FCT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).\n* ECOG performance status of 0 to 2.\n* Adequate organ and bone marrow function as described in study protocol.\n* Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.\n* Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.\n\nExclusion Criteria:\n\n* Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).\n* Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.\n* Receipt of \\> 6 cycles of PSMA-directed β-emitting therapeutic RC.\n* History of another primary malignancy, with exceptions.\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.\n* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.\n* Clinically significant ECG abnormalities, with exceptions.",{"count":653,"type":24},670,[218],"The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.",[657],"Metastatic Castration-resistant Prostate Cancer",[659],"AZD2265; prostate cancer; mCRPC; PSMA; FPI-2265; 225Ac",{"date":462,"type":39},{"date":662,"type":39},"2026-05-04",{"date":664,"type":24},"2029-12-20",{"name":45,"class":46},104,""]