RecruitingPhase 1Phase 2NCT06130553

A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors

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 Participants With Advanced/Metastatic Solid Tumors That Are MTAP Deficient


Sponsor

AstraZeneca

Enrollment

334 participants

Start Date

Jan 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AZD3470 and a drug called Datopotamab deruxtecan for people with advanced solid tumors that are mtap deficient. The study is currently recruiting participants at 21 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD3470

AZD3470 is a novel, potent and selective, second-generation, MTAP-selective, inhibitor of PRMT5.

DRUGDatopotamab deruxtecan

AZD3470 in combination with Dato-DXd + Dato-Dxd monotherapy


Locations(21)

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

Chengdu, China

Research Site

Shanghai, China

Research Site

Wuhan, China

Research Site

Villejuif, France

Research Site

Chūōku, Japan

Research Site

Kashiwa, Japan

Research Site

Amsterdam, Netherlands

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

Research Site

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT06130553