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AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Sponsor: AstraZeneca
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)
Official title: A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
163
Start Date
2023-12-29
Completion Date
2027-06-29
Last Updated
2026-01-16
Healthy Volunteers
No
Interventions
AZD0486
Investigational Product administered via intravenous infusion.
Locations (79)
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Birmingham, Alabama, United States
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Duarte, California, United States
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Los Angeles, California, United States
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Palo Alto, California, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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New York, New York, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Melbourne, Australia
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Porto Alegre, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Changsha, China
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Chengdu, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Nanjing, China
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Nanjing, China
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Suzhou, China
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Tianjin, China
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Zhengzhou, China
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Caen, France
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Marseille, France
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Nantes, France
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Paris, France
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Pierre-Bénite, France
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Toulouse, France
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Cologne, Germany
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Düsseldorf, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Halle, Germany
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Hamburg, Germany
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München, Germany
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Münster, Germany
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Würzburg, Germany
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Bergamo, Italy
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Bologna, Italy
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Monza, Italy
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Naples, Italy
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Roma, Italy
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Bunkyō City, Japan
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Chiba, Japan
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Chūōku, Japan
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Fukuoka, Japan
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Kashiwa, Japan
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Kyoto, Japan
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Okayama, Japan
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Osaka, Japan
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Sapporo, Japan
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Toyohashi, Japan
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Yamagata, Japan
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Salamanca, Spain
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Valencia, Spain
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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London, United Kingdom
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Manchester, United Kingdom
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Surrey, United Kingdom