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A trial to learn how safe AZD4512 is and how it works in the bodies of people with B-cell acute lymphoblastic leukemia (B-ALL)
EU CTIS ID: 2025-522372-93-00
What this study is testing
Module 1 Dose Escalation: To assess the safety and tolerability of AZD4512 in participants with R/R B-ALL [Ph(-) and Ph(+)] as defined by NCCN guidelines Module 1 Dose Escalation: To identify the MTD and/or doses of AZD4512 for subsequent evaluation in Module 2 Module 2 Dose Optimization:To evaluate the efficacy and determine the RP2D of AZD4512 in participants with R/R Ph(-) B-ALL based on NCCN response criteria Module 2 Dose Optimization: To assess the safety and tolerability of AZD4512 in participants with R/R Ph(-) B-ALL
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age: ≥ 16 years old in Module 1 (US only: ≥18year) ≥ 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) - Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL – R/R - 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
You likely can't join if
- 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 5 half-lives -Strong inhibitors of CYP 3A4 within 14 days or 5 half-lives (whichever is longer) -Investigational agents or study interventions in the last 30 days or 5 half-lives prior to the first dose of AZD4512 whichever is longer. 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.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Australia
- Canada
- United States
- China
- United Kingdom
- Taiwan
- Korea, Democratic People's Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Australia; Canada; United States; China; United Kingdom and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.