drugset / Trial / NCT04655183

Study of M4344 in Combination With Niraparib

NCT04655183

RandomizedParallel-groupOpen-labelTreatment

Summary

Study will include 3 parts. Aim of Part 1 of this study is to establish the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) for M4344 (is an Ataxia Telangiectasia Mutated and Rad3-related \[ATR\] inhibitors) in combination with niraparib in participants with advanced solid tumors. Aim of Parts 2 and 3 of the study is to provide clinical proof-of-concept for the preclinically predicted synergistic efficacy of ATR and poly(ADP-Ribose) polymerase (PARP) inhibitors (PARPi) in defined populations of participants with advanced breast cancer (aBC) with DDR mutations with an unmet medical need.

Timeline

Start
2020-12-01
Primary completion
2023-09-01
Completion
2023-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject M4344 Small molecule
Subject Niraparib Small molecule Oral

Indications