[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054149":3},{"organization":4,"outcomesModule":7,"designInfo":109,"detailedDescription":115,"studyPopulation":19,"armGroups":116,"interventions":127,"overallOfficials":19,"centralContacts":133,"locations":139,"responsibleParty":369,"collaborators":371,"id":374,"slug":19,"hasResults":375,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":375,"sex":381,"minAge":382,"maxAge":19,"enrollmentInfo":383,"targetDuration":19,"studyType":386,"phases":387,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":142,"whyStopped":19,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":408},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":19},[9,13,17,20,22,26,28,30],{"measure":10,"description":11,"timeFrame":12},"Module 1 (Dose Escalation): Number of participants with dose-limiting toxicities (DLTs).","DLTs are dose-limiting toxicities as defined in the study protocol.","From first dose up to 21 days (DLT period).",{"measure":14,"description":15,"timeFrame":16},"Module 1 (Dose Escalation): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)","Assessed by the CTCAE criteria version 5.0","From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)",{"measure":18,"description":19,"timeFrame":16},"Module 1 (Dose Escalation): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs",null,{"measure":21,"description":19,"timeFrame":16},"Module 1 (Dose Escalation): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signs",{"measure":23,"description":24,"timeFrame":25},"Module 2 (Dose Optimization): Overall response rate (ORR) in participants with R\u002FR Ph(-) B-ALL","To evaluate the efficacy based on NCCN response criteria, measured by ORR (CR\u002FCRh)","From date of first dose of AZD4512 up until end of study, up to 38 months",{"measure":27,"description":15,"timeFrame":16},"Module 2 (Dose Optimization): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)",{"measure":29,"description":19,"timeFrame":16},"Module 2 (Dose Optimization): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs",{"measure":31,"description":19,"timeFrame":16},"Module 2 (Dose Optimization): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signs",[33,36,38,40,42,44,46,48,50,53,56,58,60,62,65,67,69,71,74,76,78,80,82,84,86,89,92,94,96,98,100,102,104,106],{"measure":34,"description":35,"timeFrame":16},"Module 1 (Dose Escalation): Plasma PK parameters of AZD4512","To characterize the PK of AZD4512 as monotherapy in participants with R\u002FR B-ALL.",{"measure":37,"description":35,"timeFrame":16},"Module 1 (Dose Escalation): Total antibody and total unconjugated payload",{"measure":39,"description":35,"timeFrame":16},"Module 1 (Dose Escalation): Area Under Curve (AUC)",{"measure":41,"description":35,"timeFrame":16},"Module 1 (Dose Escalation): Peak Plasma Concentration (Cmax)",{"measure":43,"description":35,"timeFrame":16},"Module 1 (Dose Escalation): Time to max concentration (Tmax)",{"measure":45,"description":35,"timeFrame":16},"Module 1 (Dose Escalation): Half life (T1\u002F2)",{"measure":47,"description":35,"timeFrame":16},"Module 1 (Dose Escalation): Clearance (CL)",{"measure":49,"description":35,"timeFrame":16},"Module 1 (Dose Escalation): Volume of distribution (Vz)",{"measure":51,"description":52,"timeFrame":16},"Module 1 (Dose Escalation): Number and percentage of participants who develop anti-drug antibodies (ADAs)","To determine the immunogenicity of AZD4512 as monotherapy in participants with R\u002FR B-ALL.",{"measure":54,"description":55,"timeFrame":25},"Module 1 (Dose Escalation): Objective Response Rate (ORR): proportion of participants with CR or CRh","To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R\u002FR B-ALL \\[Ph(-) and Ph(+)\\] as defined by NCCN guidelines",{"measure":57,"description":55,"timeFrame":25},"Module 1 (Dose Escalation): Composite Complete Remission (CRc) rate: proportion of participants with CR, CRh, or CRi",{"measure":59,"description":55,"timeFrame":25},"Module 1 (Dose Escalation): Complete Remission (CR) rate",{"measure":61,"description":55,"timeFrame":25},"Module 1 (Dose Escalation): Time to Response (TTR)",{"measure":63,"description":64,"timeFrame":25},"Module 1 (Dose Escalation): Duration of Response (DoR)","\\- To evaluate the preliminary efficacy of AZD4512 as monotherapy in participants with R\u002FR B-ALL \\[Ph(-) and Ph(+)\\] as defined by NCCN guidelines",{"measure":66,"description":64,"timeFrame":25},"Module 1 (Dose Escalation): Event-Free Survival (EFS)",{"measure":68,"description":64,"timeFrame":25},"Module 1 (Dose Escalation): Overall Survival (OS)",{"measure":70,"description":64,"timeFrame":25},"Module 1 (Dose Escalation): Percentage of participants who receive subsequent allogeneic hematopoietic stem cell transplant (HSCT)",{"measure":72,"description":73,"timeFrame":25},"Module 2 (Dose Optimization): Complete Remission (CR) rate","To evaluate the efficacy of AZD4512 as monotherapy in participants with R\u002FR B-ALL \\[Ph(-)\\] as defined by NCCN guidelines",{"measure":75,"description":73,"timeFrame":25},"Module 2 (Dose Optimization):Composite Complete Remission (CRc) rate: proportion of participants with CR, CRh, or CRi",{"measure":77,"description":73,"timeFrame":25},"Module 2 (Dose Optimization):Time to Response (TTR)",{"measure":79,"description":73,"timeFrame":25},"Module 2 (Dose Optimization): Duration of Response (DoR)",{"measure":81,"description":73,"timeFrame":25},"Module 2 (Dose Optimization):Event-Free Survival (EFS)",{"measure":83,"description":73,"timeFrame":25},"Module 2 (Dose Optimization): Overall Survival (OS)",{"measure":85,"description":73,"timeFrame":25},"Module 2 (Dose Optimization): Percentage of participants who receive subsequent allogeneic hematopoietic stem cell transplant (HSCT)",{"measure":87,"description":88,"timeFrame":25},"Module 2 (Dose Optimization): MRD-negative CR rate, CR\u002FCRh (ORR), CR\u002FCRi\u002FCRh (CRc) rate","To evaluate the impact of AZD4512 on MRD as assessed by NGS (central)",{"measure":90,"description":91,"timeFrame":16},"Module 2 (Dose Optimization): Plasma PK parameters of AZD4512","To characterize the PK of AZD4512 as monotherapy in participants with R\u002FR B-ALL \\[Ph(-)\\]",{"measure":93,"description":91,"timeFrame":16},"Module 2 (Dose Optimization): total antibody and total unconjugated payload",{"measure":95,"description":91,"timeFrame":16},"Module 2 (Dose Optimization): Area Under Curve (AUC)",{"measure":97,"description":91,"timeFrame":16},"Module 2 (Dose Optimzation): Peak Plasma Concentration (Cmax)",{"measure":99,"description":91,"timeFrame":16},"Module 2 (Dose Optimization): Time to max concentration (Tmax)",{"measure":101,"description":91,"timeFrame":16},"Module 2 (Dose Optimization): Half life (T1\u002F2)",{"measure":103,"description":91,"timeFrame":16},"Module 2 (Dose Optimization): Clearance (CL)",{"measure":105,"description":91,"timeFrame":16},"Module 2 (Dose Optimization): Volume of distribution (Vz)",{"measure":107,"description":108,"timeFrame":16},"Module 2 (Dose Optimization): Summary of of pre-existing and treatment induced ADAs for AZD4512 (positive or negative, titers)","To determine the immunogenicity of AZD4512 as monotherapy in participants with R\u002FR B-ALL \\[Ph(-)\\]",{"allocation":110,"interventionModel":111,"interventionModelDescription":19,"primaryPurpose":112,"observationalModel":19,"timePerspective":19,"maskingInfo":113},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":114,"maskingDescription":19,"whoMasked":19},"NONE","In this Phase I\u002FII, open-label multi-center study AZD4512 will be administered to adult\u002Fyoung adult patients (Module 1: \\>=16 years; Module 2: \\>=12 years) with relapsed\u002Frefractory B-Cell acute lymphoblastic leukemia (B-ALL). This study will have 2 parts: Module 1 - Dose Escalation and Module 2 - Dose Optimization.",[117,123],{"label":118,"type":119,"description":120,"interventionNames":121},"Module 1 Dose Escalation","EXPERIMENTAL","Module 1 will evaluate escalating doses of AZD4512 as monotherapy to determine the maximum tolerated dose (MTD) and\u002For doses of AZD4512 for subsequent evaluation in Module 2 (dose optimization), in participants with relapsed\u002Frefractory (R\u002FR) Philadelphia chromosome positive (Ph\\[+\\]) and negative (Ph\\[-\\]) B-ALL, R\u002FR as defined by National Comprehensive Cancer Network (NCCN) guidelines.",[122],"Combination Product: AZD4512 monotherapy",{"label":124,"type":119,"description":125,"interventionNames":126},"Module 2 Dose Optimization","Module 2 will randomize participants with R\u002FR (as defined by NCCN guidelines) Ph(-) BALL only across 2 to 3 dose levels identified in Module 1 to receive AZD4512 monotherapy for further exploration of the doses. The aim of Module 2 is to identify the recommended Phase 2 dose (RP2D) of AZD4512 monotherapy, evaluate the efficacy and further define the safety profile of AZD4512.",[122],[128],{"type":129,"name":130,"description":131,"armGroupLabels":132,"otherNames":19},"COMBINATION_PRODUCT","AZD4512 monotherapy","Patients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22",[118,124],[134],{"name":135,"role":136,"phone":137,"phoneExt":19,"email":138},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[140,154,164,173,182,191,200,210,222,231,241,249,259,267,276,281,286,291,301,309,317,325,333,343,351,361],{"facility":141,"status":142,"city":143,"state":144,"zip":145,"country":146,"countryCode":147,"cosmosGeoPoint":148,"geoPoint":153,"contacts":19},"Research Site","RECRUITING","Duarte","California","91010","United 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Columbia","V5Z 1M9","Canada","CA",{"type":149,"coordinates":218},[219,220],-123.11934,49.24966,{"lat":220,"lon":219},{"facility":141,"status":142,"city":223,"state":224,"zip":225,"country":215,"countryCode":216,"cosmosGeoPoint":226,"geoPoint":230,"contacts":19},"Toronto","Ontario","M5G 1X6",{"type":149,"coordinates":227},[228,229],-79.39864,43.70643,{"lat":229,"lon":228},{"facility":141,"status":211,"city":232,"state":19,"zip":233,"country":234,"countryCode":235,"cosmosGeoPoint":236,"geoPoint":240,"contacts":19},"Guangzhou","510515","China","CN",{"type":149,"coordinates":237},[238,239],113.25,23.11667,{"lat":239,"lon":238},{"facility":141,"status":211,"city":242,"state":19,"zip":243,"country":234,"countryCode":235,"cosmosGeoPoint":244,"geoPoint":248,"contacts":19},"Tianjin","301600",{"type":149,"coordinates":245},[246,247],117.17667,39.14222,{"lat":247,"lon":246},{"facility":141,"status":142,"city":250,"state":19,"zip":251,"country":252,"countryCode":253,"cosmosGeoPoint":254,"geoPoint":258,"contacts":19},"Bunkyō City","113-8677","Japan","JP",{"type":149,"coordinates":255},[256,257],139.4217,35.5331,{"lat":257,"lon":256},{"facility":141,"status":142,"city":260,"state":19,"zip":261,"country":252,"countryCode":253,"cosmosGeoPoint":262,"geoPoint":266,"contacts":19},"Chūōku","104-0045",{"type":149,"coordinates":263},[264,265],130.67068,33.63867,{"lat":265,"lon":264},{"facility":141,"status":142,"city":268,"state":19,"zip":269,"country":270,"countryCode":19,"cosmosGeoPoint":271,"geoPoint":275,"contacts":19},"Seoul","03080","South Korea",{"type":149,"coordinates":272},[273,274],126.9784,37.566,{"lat":274,"lon":273},{"facility":141,"status":142,"city":268,"state":19,"zip":277,"country":270,"countryCode":19,"cosmosGeoPoint":278,"geoPoint":280,"contacts":19},"06351",{"type":149,"coordinates":279},[273,274],{"lat":274,"lon":273},{"facility":141,"status":142,"city":268,"state":19,"zip":282,"country":270,"countryCode":19,"cosmosGeoPoint":283,"geoPoint":285,"contacts":19},"06591",{"type":149,"coordinates":284},[273,274],{"lat":274,"lon":273},{"facility":141,"status":142,"city":268,"state":19,"zip":287,"country":270,"countryCode":19,"cosmosGeoPoint":288,"geoPoint":290,"contacts":19},"3722",{"type":149,"coordinates":289},[273,274],{"lat":274,"lon":273},{"facility":141,"status":211,"city":292,"state":19,"zip":293,"country":294,"countryCode":295,"cosmosGeoPoint":296,"geoPoint":300,"contacts":19},"Badalona(Barcelona)","08916","Spain","ES",{"type":149,"coordinates":297},[298,299],2.24741,41.45004,{"lat":299,"lon":298},{"facility":141,"status":142,"city":302,"state":19,"zip":303,"country":294,"countryCode":295,"cosmosGeoPoint":304,"geoPoint":308,"contacts":19},"Barcelona","08035",{"type":149,"coordinates":305},[306,307],2.15899,41.38879,{"lat":307,"lon":306},{"facility":141,"status":142,"city":310,"state":19,"zip":311,"country":294,"countryCode":295,"cosmosGeoPoint":312,"geoPoint":316,"contacts":19},"Salamanca","37007",{"type":149,"coordinates":313},[314,315],-5.66388,40.96882,{"lat":315,"lon":314},{"facility":141,"status":142,"city":318,"state":19,"zip":319,"country":294,"countryCode":295,"cosmosGeoPoint":320,"geoPoint":324,"contacts":19},"Santander","39008",{"type":149,"coordinates":321},[322,323],-3.80493,43.46589,{"lat":323,"lon":322},{"facility":141,"status":155,"city":326,"state":19,"zip":327,"country":294,"countryCode":295,"cosmosGeoPoint":328,"geoPoint":332,"contacts":19},"Valencia","46026",{"type":149,"coordinates":329},[330,331],-0.37966,39.47391,{"lat":331,"lon":330},{"facility":141,"status":142,"city":334,"state":19,"zip":335,"country":336,"countryCode":337,"cosmosGeoPoint":338,"geoPoint":342,"contacts":19},"Taichung","40705","Taiwan","TW",{"type":149,"coordinates":339},[340,341],120.6839,24.1469,{"lat":341,"lon":340},{"facility":141,"status":142,"city":344,"state":19,"zip":345,"country":336,"countryCode":337,"cosmosGeoPoint":346,"geoPoint":350,"contacts":19},"Taipei","106",{"type":149,"coordinates":347},[348,349],121.52639,25.05306,{"lat":349,"lon":348},{"facility":141,"status":142,"city":352,"state":19,"zip":353,"country":354,"countryCode":355,"cosmosGeoPoint":356,"geoPoint":360,"contacts":19},"Bloomsbury","W1T 7HA","United Kingdom","UK",{"type":149,"coordinates":357},[358,359],-0.12252,51.52228,{"lat":359,"lon":358},{"facility":141,"status":142,"city":362,"state":19,"zip":363,"country":354,"countryCode":355,"cosmosGeoPoint":364,"geoPoint":368,"contacts":19},"Manchester","M20 4BX",{"type":149,"coordinates":365},[366,367],-2.23743,53.48095,{"lat":367,"lon":366},{"type":370,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[372],{"name":373,"class":6},"Fortrea","100054149",false,"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.","ALL","12 Years",{"count":384,"type":385},83,"ESTIMATED","INTERVENTIONAL",[388,389],"PHASE1","PHASE2","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).",[392],"B-cell Acute Lymphoblastic Leukemia (B-ALL)",[394,395,396,397,398],"Acute lymphoblastic leukemia (B-ALL)","Dose escalation","Dose optimization","Cluster of differentiation 22 (CD22)","Antibody-drug conjugate (ADC)","2026-07-10",{"date":401,"type":402},"2026-07-13","ACTUAL",{"date":404,"type":402},"2025-11-12",{"date":406,"type":385},"2028-07-03",{"name":5,"class":6},26]