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NCT06137118PHASE1, PHASE2Recruiting

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

AstraZeneca

Start Date

12/29/2023

Completion Date

6/29/2027

Summary

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

Detailed Description

This dose escalation and optimization study is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy in r/r B-ALL.

Eligibility Criteria

Age Range: 12 years to No maximum

Inclusion Criteria: * Age: 12 years and above (Parts A, B and C). * Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with: 1. Bone marrow infiltration with \>/= 5% blasts 2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option. 3. Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs. * For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. For Participants 16 years or younger, Lansky score more or equal to 50%. The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria). * Isolated extramedullary disease relapse. * Testicular leukemia * History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy. * History of other malignancy (with certain exceptions). * Unresolved AEs \>/= Grade 2, from prior therapies * Prior therapy with TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy. * GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment. The above is a summary, other exclusion criteria details may apply.

Interventions

DRUG

AZD0486

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Conditions

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Locations

Research Site

Birmingham, Alabama 35233

United States

Research Site

Duarte, California 91010

United States

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Los Angeles, California 90048

United States

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Palo Alto, California 94304

United States

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Tampa, Florida 33612

United States

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Atlanta, Georgia 30322

United States

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Chicago, Illinois 60637

United States

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New York, New York 10016

United States

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Houston, Texas 77030

United States

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Richmond, Virginia 23298

United States

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Seattle, Washington 98109

United States

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Milwaukee, Wisconsin 53226

United States

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Melbourne, 3000

Australia

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Porto Alegre, 90035903

Brazil

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São Paulo, 01401-002

Brazil

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São Paulo, 05652-900

Brazil

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Toronto, Ontario M5G 2M9

Canada

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Montreal, Quebec H3T1C5

Canada

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Montreal, Quebec H4A 3J1

Canada

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Changsha, 410008

China

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Chengdu, 610041

China

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Guangzhou, 510060

China

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Guangzhou, 510280

China

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Hangzhou, 310003

China

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Nanjing, 210008

China

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Nanjing, 210009

China

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Suzhou, 215004

China

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Tianjin, 300020

China

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Zhengzhou, 450008

China

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Caen, 14033

France

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Marseille, 13009

France

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Nantes, 44000

France

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Paris, 75019

France

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Pierre-Bénite, 69495

France

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Toulouse, 31059

France

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Cologne, 50924

Germany

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Düsseldorf, 40225

Germany

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Essen, 45147

Germany

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Frankfurt, 60590

Germany

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Freiburg im Breisgau, 79106

Germany

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Halle, 06120

Germany

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Hamburg, 20246

Germany

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Kiel, 24105

Germany

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München, D-81337

Germany

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Münster, 48149

Germany

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Würzburg, 97080

Germany

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Bergamo, 24127

Italy

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Bologna, 40138

Italy

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Monza, 20900

Italy

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Naples, 80123

Italy

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Roma, 00165

Italy

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Bunkyō City, 113-8677

Japan

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Chiba, 260-8677

Japan

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Chūōku, 104-0045

Japan

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Fukuoka, 810-8563

Japan

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Kashiwa, 277-8577

Japan

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Kyoto, 606-8507

Japan

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Okayama, 701-1192

Japan

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Osaka, 545-8586

Japan

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Sapporo, 003-0006

Japan

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Toyohashi, 441-8570

Japan

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Yamagata, 990-9585

Japan

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Seoul, 03080

South Korea

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Seoul, 03722

South Korea

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Seoul, 06351

South Korea

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Seoul, 6591

South Korea

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Barcelona, 08036

Spain

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Barcelona, 8035

Spain

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Madrid, 28025

Spain

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Madrid, 28046

Spain

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Salamanca, 37007

Spain

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Valencia, 46026

Spain

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Kaohsiung City, 833401

Taiwan

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Taichung, 40705

Taiwan

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Tainan, 70403

Taiwan

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Taipei, 10002

Taiwan

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Taoyuan, 333

Taiwan

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London, EC1A 7BE

United Kingdom

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Manchester, M20 4BX

United Kingdom

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Surrey, SM1 2DL

United Kingdom