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AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Trial Status: active
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)
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:
Bone marrow infiltration with >/= 5% blasts
Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06137118.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Virginia
Richmond
VCU Massey Comprehensive Cancer Center
Status: Active
Name Not Available
This dose escalation and optimization study is evaluating the safety, tolerability, PK,
PD and clinical activity of AZD0486 monotherapy in r/r B-ALL.