NCT04655183

Study of M4344 in Combination With Niraparib

A Phase I Dose Escalation Study of ATR Inhibitor M4344 in Combination With Niraparib in Participants With Advanced Solid Tumors Followed by Phase II Cohort Expansion in Participants With Breast Cancer With DNA Damage Response (DDR) Mutations

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib will be administered orally, once daily.
DRUG	M4344	M4344 will be administered once daily or on an intermittent schedule in combination with niraparib.
DRUG	Niraparib	Niraparib will be administered orally once daily at the RDE as determined in Part 1 of this study.
DRUG	M4344	M4344 will be administered at a dose and schedule that was determined as RDE in Part 1A in combination with niraparib.
DRUG	Niraparib	Niraparib will be administered orally, once daily. Dose of niraparib will be escalated beyond the dose in Part 1A.
DRUG	Niraparib	Niraparib will be administered as single agent at the approved dose.

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2020-12-07
• Last updated: 2021-06-30

Regulatory

• FDA-regulated drug study