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 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)

Trial Details

NCT ID
NCT06137118
Phase
PHASE1 / PHASE2
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • AZD0486
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Duarte, California, United States|34.13945,-117.97729
  • Tampa, Florida, United States|27.94752,-82.45843
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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