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Brief Title: A Study of AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient Advanced/Metastatic Solid Tumours
Official Title: 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 Tumours That Are MTAP Deficient
Study ID: NCT06130553
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 tumours with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.
Detailed Description: This first time in human, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumours with MTAP deficiency follows a modular design. Module 1 will include dose escalation and DDI (Part A) and dose optimisation and expansion (Part B). New modules for combination treatments may be added in the future based on emerging data.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, San Francisco, California, United States
Research Site, West Hollywood, California, United States
Research Site, New Haven, Connecticut, United States
Research Site, Baltimore, Maryland, United States
Research Site, Portland, Oregon, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Providence, Rhode Island, United States
Research Site, Fairfax, Virginia, United States
Research Site, Melbourne, , Australia
Research Site, Beijing, , China
Research Site, Shanghai, , China
Research Site, Villejuif, , France
Research Site, Chuo-ku, , Japan
Research Site, Kashiwa, , Japan
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Amsterdam, , Netherlands
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain