M9466 as Single Agent or in Combination With Tuvusertib in Advanced Solid Tumors (DDRiver 501) - Trial NCT06421935
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.
Study Focus
Sponsor & Location
EMD Serono Research & Development Institute, Inc.
EMD Serono
Timeline & Enrollment
Phase 1
Jul 01, 2024
Mar 26, 2026
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
Data Source
ClinicalTrials.gov
NCT06421935
Non-Device Trial