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 (PRIMAVERA)

Research summary

This is a FTiH modular, Phase I/II, open-label, multicentre, dose escalation and expansion study in participants with r/r haematologic malignancies. The study consists of several study modules, each evaluating the safety, tolerability, PK, pharmacodynamics, and efficacy of orally administered AZD3470 as monotherapy and in combination with other anticancer agents. This study will follow a modular protocol design evaluating AZD3470 as monotherapy and in combination with other anticancer agents. New cohorts (including further monotherapy expansion) and new modules for combination treatments may be added as protocol amendments in the future based on emerging supportive preclinical and/or clinical data. Study information applicable to all participants in this study is described in the core sections of this protocol. The rationale for each study treatment and cohort, and specific study information and assessments, will be described in each separate module. This study is planned to take place in approximately 20 centres across 10 countries.

Principal Investigator

Dr Graham Collins

Contact us

Email: orh-tr.earlyphasenurses@nhs.net

IRAS number

1009368