AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

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+)

Trial Details

NCT ID
NCT06137118
Phase
PHASE1 / PHASE2
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • AZD0486
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Palo Alto, California, United States|37.44188,-122.14302
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility 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:
  • 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 …

For full eligibility, visit ClinicalTrials.gov.

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