RecruitingPhase 1Phase 2NCT07109219
Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
A Modular Phase I/II, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AZD4512 Monotherapy or in Combination With Anticancer Agent(s) in Participants With Acute Lymphoblastic Leukemia
Sponsor
AstraZeneca
Enrollment
83 participants
Start Date
Nov 12, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
Eligibility
Min Age: 12 Years
Inclusion Criteria12
- \. Age:
- years old in Module 1 (US only: ≥18year)
- years old in Module 2
- \. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022).
- 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
- \. Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50)
- \. Peripheral lymphoblast count \< 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified criteria)
- \. At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available. Participants who have received prior CD22 targeted therapies are eligible.
- 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
- \. Prior DLI \>4 weeks, prior cell therapy or autoHSCT \>8 weeks, alloHSCT \>12 weeks
Exclusion Criteria11
- Burkitt lymphoma and leukemia
- Isolated extramedullary disease; Active testicular or CNS (\> CNS1) involvement
- Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy)
- 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
- 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.
Interventions
COMBINATION_PRODUCTAZD4512 monotherapy
Patients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22
Locations(26)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07109219
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