Clinical Trial 23453

• Overview

  Study Title:

  A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

  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 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)

  Objective:

  Part A: Phase 1 Dose Escalation Primary Objectives: To assess the safety and tolerability of AZD0486 in participants with Ph(+) or Ph(-) R/R B-ALL, aged 16 to 80 years, inclusive. Secondary Objectives: To evaluate the preliminary efficacy of AZD0486 based on NCCN response criteria by local investigators. To characterise the PK of AZD0486 as monotherapy. To evaluate the immunogenicity of AZD0486 as monotherapy. Part B: Dose Optimisation Primary Objectives: To evaluate the preliminary efficacy of AZD0486 based on NCCN response criteria. To assess the safety and tolerability of AZD0486 in participants with R/R Ph(-) B-ALL, aged 12 to 80 years, inclusive. Secondary Objectives: To evaluate the efficacy of AZD0486 based on NCCN response criteria. To evaluate the impact of AZD0486 on MRD-negative CR rate. To characterise the PK of AZD0486 as monotherapy. To determine the immunogenicity of AZD0486 as monotherapy.

• Treatments

  Therapies:

  Immunomodulators

  Medications:

  AZD0486 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • 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 Part A 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%.
  • Other criteria apply

• Exclusion Criteria

  Key Exclusion Criteria:
  • 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.
  • Other criteria apply

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