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Clinical Trials List

Protocol NumberD7405C00001
NCT Number(ClinicalTrials.gov Identfier)NCT06137118
Active

2023-12-01 - 2027-03-01

Phase I/II

Recruiting5

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 Leukaemia

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 滕傑林 Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator MING YAO Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉鴻霖 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Chung Kao Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Objectives

This is a Phase 1/2, global multicenter, open-label, single-arm, dose-escalation and dose-optimized trial of AZD0486 monotherapy in patients with R/R B who have received ≥ 2 prior lines of therapy. ‐Safety, tolerability, and efficacy in ALL subjects. This trial will consist of 3 consecutive parts, detailed below. Part A subjects will be assigned to treatment sequentially based on time slot availability. The trial sponsor may also decide to extend the backfill of a cohort in which signs of clinical activity were observed to further accumulate data to support decisions about optimal dosage and treatment schedule. Group management plans will be used to control time slot allocation. Part B subjects will be randomly assigned to treatment groups in a 1:1 ratio. However, if the Safety Review Committee (SRC) recommends that enrollment in a specific dose level cohort be suspended, enrollment in other dose level cohorts may continue. In Part C, all subjects will be assigned to receive the RP2D selected in Part B.

Test Drug

AZD0486

Active Ingredient

AZD0486

Dosage Form

vial

Dosage

2 mg/ml

Endpoints

Part A: Dose Escalation
Frequency of dose-limiting toxicities (DLTs)
Frequency, severity, and relationship to study drug of AEs and SAEs; dose adjustments; changes in laboratory assessments; QTc and vital sign changes
Part B: Dose Optimization
An analysis set of subjects was evaluable for ORR, defined as the proportion of subjects achieving CR/CRi after up to 3 cycles
Frequency, severity, and relationship to study drug of AEs and SAEs; dose adjustments; changes in laboratory assessments; QTc and vital sign changes.
Part C: Efficacy Expansion
An analysis set of subjects was evaluable for ORR, defined as the proportion of subjects achieving CR/CRi after up to 3 cycles

Inclution Criteria

Inclusion Criteria:

-Age: 16 years and older (Part A), 12 years and older (Parts B and C).
-Participants with CD19+ B-cell Acute Lymphoblastic Leukemia 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.
-Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2 OR Lansky score more or equal to 50%.

Exclusion Criteria

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.

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    251 participants

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