AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Hematopoietic Malignancies
Leukemia
Unknown Primary
12 Years and older, Male and Female
D7405C00001 (primary)
NCI-2023-11025
2018-002011-10
Summary
This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose
optimization study of surovatamig (AZD0486) to evaluate the safety, tolerability, and
efficacy of surovatamig (AZD0486) monotherapy in participants with R/R B ALL. The study
will consist of 4 parts. Part A: monotherapy dose escalation in 3L+ B-ALL. Part B: dose
optimization in 3L+ B-ALL. Part C: Dose expansion in 3L+ B-ALL. Part D: Dose optimization
and efficacy expansion in R/R B-ALL (2L+)
Objectives
This dose escalation and optimization study is evaluating the safety, tolerability, PK,
PD and clinical activity of surovatamig (AZD0486) monotherapy in r/r B-ALL.
Eligibility
- Age: 12 years and above (Parts A, B, C and D).
- 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 (Parts A, B, C); or relapsed or refractory to =1 prior line of therapy (Part D).
- 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.
Treatment Sites in Georgia
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