A Study of AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors
Trial Parameters
Brief 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.
Eligibility Criteria
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 tumors defined as evidence of homozygous deletion of one or more exons of the MTAP gene in tumor tissue AND/OR loss of MTAP expression in the tumor tissue. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * A minimum life expectance of 12 weeks in the opinion of the Investigator. * Participants must have at least one measurable lesion according to Response Evaluation Criteria i