Overview

Study of M4344 in Combination With Niraparib

Status:
Withdrawn

Trial end date:
2023-09-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

EMD Serono Research & Development Institute, Inc.

Collaborator:

Merck KGaA, Darmstadt, Germany

Treatments:

Niraparib