Phase III Study of AZD4512 Alone or with Other Cancer Medicines in Adults With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating AZD4512, an antibody-drug conjugate targeting CD22, for its safety and effectiveness in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma B-NHL. This Phase III open-label global study explores AZD4512 alone or combined with other anticancer agents, focusing on participants who have previously undergone at least two lines of therapy. The trial also aims to study pharmacokinetics, pharmacodynamics, and immunogenicity of AZD4512 in this population. The study includes a dose escalation phase and a pharmacodynamicsafety backfill phase to determine the maximum tolerated dose or optimal biological dose of AZD4512 monotherapy. Participants receive AZD4512 through intravenous infusion, and additional modules may be added to study specific B-NHL subtypes or combination treatments. This modular design allows for assessment of AZD4512 alone or with other anticancer agents across various B-NHL subgroups. Participants will be monitored for dose-limiting toxicities, adverse events, and changes in vital signs or laboratory tests from the first dose through 30 days after the last dose. Long-term outcomes such as response rates, duration of response, progression-free survival, overall survival, and drug pharmacokinetics will be followed for up to two years. Safety and efficacy data collected will help understand AZD4512s impact on this patient population under medical supervision.

A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma