Phase III Study Evaluating AZD4512 Alone or With Other Cancer Medicines in Patients 12 Years and Older With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are studying AZD4512, an antibody-drug conjugate targeting CD22, in patients aged 12 years and older with relapsed or refractory B-Cell acute lymphoblastic leukemia B-ALL. This Phase III open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and effectiveness of AZD4512 in this patient group. The study includes two parts a dose escalation phase and a dose optimization phase. In the first part Module 1, adult and young adult participants aged 16 years and older receive increasing doses of AZD4512 alone to find the maximum tolerated dose and suitable doses for further study. The second part Module 2 involves participants aged 12 years and older with a specific type of B-ALL receiving AZD4512 monotherapy at doses identified in Module 1. Participants in Module 2 are randomized to receive one of two to three dose levels to identify the recommended dose for Phase 2 and evaluate the drugs safety and efficacy. Participants will be monitored closely throughout the study with assessments including laboratory tests, ECGs, performance status, and vital signs. Researchers will track adverse events, dose modifications, and response rates up to 38 months. Pharmacokinetic parameters will be measured during treatment and for about six months after the last dose. The study monitors overall response, survival, and potential need for stem cell transplant. The total study duration includes treatment and follow-up periods lasting up to several years.

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