NCT06130553

A Study of AZD3470, a PRMT5 Inhibitor, 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 Patients With Advanced/Metastatic Solid Tumors That Are MTAP Deficient

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Solid Tumors That Are MTAP Deficient

Interventions

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

Timeline

• Start date: 2024-01-18
• Primary completion: 2026-02-26
• Completion: 2026-02-26
• First posted: 2023-11-14
• Last updated: 2026-03-06

Locations

20 sites across 8 countries: United States, Australia, China, France, Japan, Netherlands, South Korea, Spain

Regulatory

• FDA-regulated drug study