AstraZeneca
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+)
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.
Inclusion Criteria: * 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: 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 (Parts A, B, C); or relapsed or refractory to ≥1 prior line of therapy (Part D). 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 Cooper…
Investigational Product administered via intravenous infusion.