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OncoMatch/Clinical Trials/NCT07109219

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

Official title: 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

Is NCT07109219 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies AZD4512 monotherapy for b-cell acute lymphoblastic leukemia (b-all).

Phase 1/2RecruitingAstraZenecaNCT07109219Data as of Oct 2026Location: International · 9 countries

Treatment: AZD4512 monotherapy — 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).

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Extracted eligibility criteria

Treatments studied

Other

AZD4512 monotherapy

Cancer type

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: CD22 expression

Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≥ 12

Prior therapy

Min 1 prior line

Must have received: systemic therapy — B-ALL

relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts > 5% or reappearance of blasts in PB)

Lab requirements

Blood counts

peripheral lymphoblast count < 10,000/µl (may receive cytoreduction prior to c1d1 per protocol-specified criteria)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Research Site · Duarte, California
  • Research Site · Jacksonville, Florida
  • Research Site · Chicago, Illinois
  • Research Site · Iowa City, Iowa
  • Research Site · Franklin, Tennessee

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07109219 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received systemic therapy.

Does this trial require CD22?

Yes, CD22 expression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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