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RecruitingPhase 1 / Phase 2

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests surovatamig (AZD0486) alone for B-cell acute lymphoblastic leukemia (B-ALL), a cancer of the blood and bone marrow. It is for people age 12 and older whose cancer came back or did not respond to treatment. The study checks safety, side effects, how well the drug works, and which dose to use.

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+)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 12 or older.
  • Your B-ALL cells must have a marker called CD19, as shown by a local lab test.
  • At least 5% of cells in your bone marrow must be blasts (young leukemia cells).
  • For Parts A, B, and C, cancer must have returned or not responded after at least 2 treatments, or after 1 treatment if no standard treatment option is available.
  • For Part D, cancer must have returned or not responded after at least 1 treatment.
  • If you have Philadelphia-positive B-ALL, a type with a certain gene change, TKI drugs must not have worked or you must have been unable to tolerate them.
  • If older than 16, you must have an ECOG activity score of 2 or less. If 16 or younger, you must have a Lansky activity score of at least 50%. These scores measure how well you can do daily activities.
  • Other entry rules may apply.

Who can't join

  • B-ALL is active in your brain or spinal cord, including leukemia cells in the fluid around them.
  • Your cancer has returned only outside the bone marrow, or you have leukemia in the testicles.
  • You have a history of or current serious brain or nerve problems, such as seizures, stroke, or dementia, or had Grade 4 (life-threatening) nerve-related side effects from CAR-T or TCE treatment.
  • You have had another cancer, though some exceptions are allowed.
  • You still have Grade 2 or worse (moderate or worse) side effects from earlier treatment.
  • Before study treatment, you received ADCs (antibody drugs carrying cancer medicine) within 3 weeks; TCEs (drugs that guide immune cells to cancer) within 4 weeks; CAR-T (changed immune cells) or a stem cell transplant using your own cells within 8 weeks; or a donor stem cell transplant within 12 weeks.
  • Within 3 weeks before study treatment, you needed immune-suppressing medicine for graft-versus-host disease, when donor cells attack your body.
  • Other rules may keep you from joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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%. The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria), or signs of CNS involvement. * 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 ADCs within 3 weeks, 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 above is a summary, other exclusion criteria details may apply.

Study sites (12)

AL

CA

FL

GA

IL

NY

TX

VA

WA

WI