[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601340":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":261,"collaborators":263,"id":266,"slug":24,"hasResults":267,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":267,"sex":273,"minAge":274,"maxAge":24,"enrollmentInfo":275,"targetDuration":24,"studyType":278,"phases":279,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":300},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Combination Product: AZD4512 monotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"COMBINATION_PRODUCT","AZD4512 monotherapy","Patients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[32,46,56,65,74,83,92,102,114,123,133,141,151,159,168,173,178,183,193,201,209,217,225,235,243,253],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":24},"Research Site","RECRUITING","Duarte","California","91010","United 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7HA","United Kingdom","UK",{"type":41,"coordinates":249},[250,251],-0.12252,51.52228,{"lat":251,"lon":250},{"facility":33,"status":34,"city":254,"state":24,"zip":255,"country":246,"countryCode":247,"cosmosGeoPoint":256,"geoPoint":260,"contacts":24},"Manchester","M20 4BX",{"type":41,"coordinates":257},[258,259],-2.23743,53.48095,{"lat":259,"lon":258},{"type":262,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[264],{"name":265,"class":6},"Fortrea","100601340",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":276,"type":277},83,"ESTIMATED","INTERVENTIONAL",[280,281],"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).",[284],"B-cell Acute Lymphoblastic Leukemia (B-ALL)",[286,287,288,289,290],"Acute lymphoblastic leukemia (B-ALL)","Dose escalation","Dose optimization","Cluster of differentiation 22 (CD22)","Antibody-drug conjugate (ADC)","2026-06-10",{"date":293,"type":294},"2026-06-11","ACTUAL",{"date":296,"type":294},"2025-11-12",{"date":298,"type":277},"2028-07-03",{"name":5,"class":6},26]