Status:
RECRUITING
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Lead Sponsor:
AstraZeneca
Conditions:
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief 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 par...
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
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 29 2027
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT06137118
Start Date
December 29 2023
End Date
June 29 2027
Last Update
December 4 2025
Active Locations (79)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Duarte, California, United States, 91010
3
Research Site
Los Angeles, California, United States, 90048
4
Research Site
Palo Alto, California, United States, 94304