NCT06421935

M9466 as Single Agent or in Combination With Tuvusertib in Advanced Solid Tumors (DDRiver 501)

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 (DDRiver 501)
EMD Serono Research & Development Institute, Inc.·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Advanced Solid Tumor
Drug/Device/Intervention
M9466
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
EMD Serono Research & Development Institute, Inc.
Funder
EMD Serono
Location
Rockland,Darmstadt, Germany,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jul 01, 2024
End date
Mar 26, 2026
Enrollment
70 participants
Primary outcome

Module 1 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs,Module 1 Part A1: Number of Participants with Dose Limiting Toxicity (DLT)-like events,Module 2 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466

Summary

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. Study details include:
 Study/Treatment Duration: Participants will be treated until disease progression, death,
 discontinuation, or End of Study. Visit Frequency: 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.

ICD-10 classifications
Carcinoma in situ, unspecifiedMalignant neoplasm: PrepuceMalignant neoplasm: Connective and soft tissue, unspecifiedMalignant neoplasm: ParametriumMalignant neoplasm of other connective and soft tissue
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06421935
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06421935 through Pure Global AI's free database. This Phase 1 trial is sponsored by EMD Serono Research & Development Institute, Inc. and is currently Not yet recruiting. The study focuses on Advanced Solid Tumor. Target enrollment is 70 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.