PRIMAVERA
Research type
Research Study
Full title
PRIMAVERA: A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, and Efficacy of AZD3470, a PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agent(s) in Participants With Relapsed/Refractory Haematologic Malignancies
IRAS ID
1009368
Contact name
Emma Greening
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
This study is being conducted to check if a new treatment, AZD3470, may help treat blood cancers. It is designed to block PRMT5, a protein that helps cells, including cancer cells, survive and grow. AZD3470 blocks PRMT5 in cells that gathers a substance called MTA. MTA builds up in cancer cells with low amounts MTAP enzyme so blocking PRMT5 in cells with MTAP loss may work better and cause less harm to normal tissue. Researchers want to learn if AZD3470 taken alone or with other cancer treatments is safe and works. This trial has modules based on whether AZD3470 is taken alone and the participant’s type of cancer. During the first part of Module 1 (dose escalation), a small number of participants with Hodgkins Lymphoma receive the same AZD3470 dose and observed for several weeks. After this dose is found to be safe, the dose will increase by a small amount for a new group of participants until they find the best doses to study further in a bigger group. In part 2 of Module 1 (dose expansion), researchers will look at how well the selected doses work for more participants.
This is the first study where AZD3470 is given to participants. AZD3470 is a tablet without other cancer treatments in Module 1. Participants may take AZD3470 until they are no longer benefiting from it, or for another reason.
Module 1 will recruit about 110 participants aged 18 years or older. Adolescents 15 years or older may take part in the dose expansion part once researchers have enough safety and other results from adults. Patients are screened to check eligibility before starting treatment. Throughout the study, careful monitoring will assess how AZD3470 is tolerated, the biochemical, physiologic effects on the body and how the treatment is absorbed and metabolised.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0009
Date of REC Opinion
15 Mar 2024
REC opinion
Further Information Favourable Opinion