Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia

Required: CD22 positive

Known Diagnosis of CD22-positive B-ALL

Allowed: BCR fusion with ABL1 (Philadelphia chromosome positive)

Ph(+) B-ALL - R/R

Must have received: cytotoxic chemotherapy

At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available

Must have received: CD22-targeted therapy

Participants who have received prior CD22 targeted therapies are eligible

Must have received: tyrosine kinase inhibitor — Ph+ B-ALL (Module 1 DE only)

Ph+ B-ALL (Module 1 DE only): intolerant to or have contraindications to TKI therapy or R/R disease despite treatment with at least 2 prior TKIs or at least one 3rd generation TKI

Must have received: donor lymphocyte infusion

Prior DLI >4 weeks

Must have received: cell therapy

prior cell therapy or autoHSCT >8 weeks, alloHSCT >12 weeks

Must have received: autologous stem cell transplant

autoHSCT >8 weeks

Must have received: allogeneic stem cell transplant

alloHSCT >12 weeks

Cannot have received: cytotoxic treatment

Exception: ALL maintenance medications or cytoreduction

Cytotoxic treatment within 14 days (except ALL maintenance medications or cytoreduction)

Cannot have received: biologic (immuno-oncology) treatment

Biologic (immuno-oncology) treatment within 28 days or 5 half-lives (whichever is shorter)

Cannot have received: radiation therapy

Non-CNS radiation within 2 weeks & CNS radiation within 4 weeks

Cannot have received: investigational agent

Exception: If the investigational product is an agent to treat B-ALL and meets the modality criteria, then a specific washout period must be adhered to instead.

Investigational agents or study interventions in the last 30 days or 5 half-lives prior to the first dose of AZD4512 whichever is longer