Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Pamela Munster
Headshot of Pamela Munster
Pamela Munster

Description

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.

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 Tumors That Are MTAP Deficient

Details

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.

Keywords

Advanced Solid Tumors That Are MTAP Deficient, solid tumor, MTAP deficient, Neoplasms, AZD3470, AZD3470 Monotherapy

Eligibility

Locations

  • Research Site accepting new patients
    San Francisco California 94143 United States
  • Research Site withdrawn
    West Hollywood California 90048 United States
  • Research Site accepting new patients
    Portland Oregon 97239 United States

Lead Scientist at UCSF

  • Pamela Munster
    Professor, Medicine, School of Medicine. Authored (or co-authored) 161 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT06130553
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 234 study participants
Last Updated