PRIMROSE: A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumors That Are MTAP Deficient
AstraZeneca
Summary
This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.
Description
This first time in human, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency follows a modular design. Module 1 Part A will include the dose escalation cohorts. Part B will include the dose optimization and expansion cohorts. New modules for combination treatments may be added in the future based on emerging data.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Principle Inclusion Criteria: * Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the ICF. * Willing to provide archival and/or baseline tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing. * Participants must have received and progressed, are refractory or are intolerant to standard therapy for the specific tumor type. All participants are required to have had at least one prior line of treatment in the recurrent or metastatic setting. * MTAP deficient tum…
Interventions
- DrugAZD3470
AZD3470 is a novel, potent and selective, second-generation, MTAP-selective, inhibitor of PRMT5.
Locations (20)
- Research SiteSan Francisco, California
- Research SiteWest Hollywood, California
- Research SiteNew Haven, Connecticut
- Research SiteBaltimore, Maryland
- Research SitePortland, Oregon
- Research SitePittsburgh, Pennsylvania