drugset / Trial / NCT04655183
Study of M4344 in Combination With Niraparib
Phase 1/2
Withdrawn
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | M4344 | Small molecule | — | — |
| Subject | Niraparib | Small molecule | — | Oral |