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

Launched by ASTRAZENECA · Jul 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called AZD4512 to see if it is safe and effective for treating a type of blood cancer called B-cell Acute Lymphoblastic Leukemia (B-ALL) that has come back or hasn’t responded to previous treatments. The study will look at how the medicine works alone or combined with other cancer treatments in patients whose disease is difficult to treat.

People who may be eligible for this trial are teenagers and adults (starting from age 12 or 16, depending on the study group) who have B-ALL that has relapsed (meaning the cancer has come back) or is resistant to treatment. Participants need to have had at least one or two previous treatments that didn’t work, and certain health conditions must be met, such as having a manageable number of cancer cells in the blood and being well enough to participate. The trial is not yet open for enrollment. If you join, you’ll be closely monitored to check for side effects and to see how well the medicine is working. This study is especially important for patients who have limited treatment options left, as it might offer a new approach to fighting this challenging cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 1. Age:
• • 16 years old in Module 1
• • 12 years old in Module 2
• • 2. Diagnosis: Diagnosis of B-ALL WHO (WHO-HAEM5)
• • Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \> 5% or reappearance of blasts in PB) or R/R with MRD ≥ 1% to ≤5%
• • The nº of enrolled participants with MRD ≥ 1 to ≤ 5% will be limited to 25% of the DE cohort
• • Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R/R or with MRD ≥ 1% to ≤5%
• • Backfill of Module 1 and Module 2 (DO): R/R Ph(-) B-ALL (BM blasts \>5%)
• • 3. Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50)
• • 4. Peripheral lymphoblast count \< 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified criteria)
• • 5. At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available
• • 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
• • 6. Prior DLI \>4 weeks, prior cell therapy or autoHSCT \>8 weeks, alloHSCT \>12 weeks
• Exclusion Criteria:
• • 1. Burkitt lymphoma and leukemia
• • 2. Isolated extramedullary disease; Active testicular or CNS (\> CNS1) involvement
• • 3. Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy)
• • 4. History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
• • 5. Prior/concomitant therapy
• • Cytotoxic treatment within 14 days (except ALL maintenance medications or cytoreduction)
• • Biologic (immuno-oncology) treatment within 28 days or 5 half-lives (whichever is shorter)
• • Non-CNS radiation within 2 weeks \& CNS radiation within 4 weeks
• • Medications known to prolong QTc and/or associated with Torsades de Pointes within 21 days or 5 half-lives (whichever is longer)
• • Strong inhibitors of CYP 3A4 within 21 days or 5 half-lives (whichever is longer)
• • Investigational agents or study interventions in the last 30 days