MS202659_0001
Research type
Research Study
Full title
An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 as a Single Agent and in Combination with the ATR Inhibitor Tuvusertib in Participants with Advanced Solid Tumors.
IRAS ID
1010085
Contact name
Communication Center KGaA
Contact email
Sponsor organisation
Merck Healthcare KGaA
Eudract number
2024-513492-41
Research summary
M9466 and tuvusertib both are investigational drugs that are being evaluated for the treatment of patients with different types of cancer. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 as monotherapy or in combination with tuvusertib in participants with advanced solid tumors.
Participants will be treated until disease progression, death, discontinuation, or End of Study.
Visits are every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.
- Module 1 Part A1 is the dose finding part to investigate the dose-combination toxicity relationship, identify a potential set of maximum tolerated dose(s) (MTDs) combinations, and establish the recommended dose(s) for expansion (RDEs) for the combination of M9466 and tuvusertib.
- Module 2 Part A1 is designed to understand M9466 monotherapy PK (Pharmacokinetics) and safety profiles and investigate PD (pharmacodynamics) and target engagement effects in a Western population.
A total of approximately 60 evaluable participants are planned to be enrolled in Module 1 Part A1 of the study. In Module 2 Part A1, approximately 10 evaluable participants will be enrolled.REC name
London - Central Research Ethics Committee
REC reference
24/LO/0565
Date of REC Opinion
24 Sep 2024
REC opinion
Further Information Unfavourable Opinion