*A Phase I/II study of AZD7789 in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma
Research type
Research Study
Full title
A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma
IRAS ID
1004672
Contact name
Debbie Mackenzie
Contact email
Sponsor organisation
AstraZeneca AB,
Eudract number
2021-003569-36
Clinicaltrials.gov Identifier
Research summary
Hodgkin lymphoma is a cancer of lymphocytes, a type of white blood cell important in the immune system. Classical Hodgkin lymphoma (cHL) is the more common type of this disease, which contains a particular type of cell called a Reed–Sternberg cell. Those cells are large and abnormal B lymphocytes (white blood cells that make antibodies, important in fighting infections) that lost their normal function in the immune system. cHL accounts for more than 9 in 10 cases of Hodgkin lymphoma in developed countries.
AZD7789 is a bispecific antibody, a type of anticancer drug, that can bind to specific parts of immune cells and block 2 proteins called programmed cell death protein-1 (PD-1) and T-cell immunoglobulin and mucin domain-containing protein-3 (TIM-3) allowing the immune cells to detect and destroy the cancer cells.
This study is being conducted in participants who have been diagnosed with cHL that has worsened after effective treatment (relapsed) or is unresponsive to treatment (refractory). The study will assess how safe AZD7789 is, if there are any side effects caused by AZD7789 and how severe they are. The study will also evaluate how well cHL responds to AZD7789. Participants will receive AZD7789 for a maximum of 35 cycles, or until the disease worsens, side effects are so severe that the study drug cannot be given any longer or any other reason to stop receiving the study drug.
The study will have 2 parts: Phase I dose escalation and Phase 2 dose expansion. Phase I will determine the best dose of AZD7789 that is safe and well tolerated. Phase II will evaluate the safety and effectiveness of AZD7789 at the dose level determined in Phase I.
About 180 participants will take part in this study.
This study is sponsored by AstraZeneca.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/FT/0031
Date of REC Opinion
25 Apr 2022
REC opinion
Further Information Favourable Opinion