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

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AZD4512, which targets the CD22 protein found on certain leukemia cells, either alone or combined with other cancer treatments. It is for patients with B-cell acute lymphoblastic leukemia (B-ALL) — a blood cancer — that has come back or stopped responding to treatment. **You may be eligible if (Module 1 — adults/teens):** - You are 16 or older (18 or older in the US) - You have CD22-positive B-ALL that is relapsed or refractory - You have received at least 2 prior treatments that failed, or 1 prior treatment with no remaining standard options - Your overall health is adequate (ECOG 0–2) **You may be eligible if (Module 2 — pediatric):** - You are 12 or older - You have relapsed/refractory Ph-negative B-ALL **You may NOT be eligible if:** - Your cancer does not express CD22 - Your leukemia blast count is very high (above 10,000/µL) unless reduced before starting - You have significant organ problems or other serious health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTAZD4512 monotherapy

Patients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22


Locations(26)

Research Site

Duarte, California, United States

Research Site

Jacksonville, Florida, United States

Research Site

Chicago, Illinois, United States

Research Site

Iowa City, Iowa, United States

Research Site

Franklin, Tennessee, United States

Research Site

Houston, Texas, United States

Research Site

Melbourne, Australia

Research Site

Vancouver, British Columbia, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Guangzhou, China

Research Site

Tianjin, China

Research Site

Bunkyō City, Japan

Research Site

Chūōku, Japan

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Badalona(Barcelona), Spain

Research Site

Barcelona, Spain

Research Site

Salamanca, Spain

Research Site

Santander, Spain

Research Site

Valencia, Spain

Research Site

Taichung, Taiwan

Research Site

Taipei, Taiwan

Research Site

Bloomsbury, United Kingdom

Research Site

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07109219


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