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NCT06421935 · ClinicalTrials.gov registry record · Phase 1
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
A Phase 1 study of Advanced Solid Tumor, sponsored by EMD Serono Research & Development Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 141
- Enrollment target
- 20
- Study locations
NCT06421935: Active Phase 1 study of Advanced Solid Tumor, sponsored by EMD Serono Research & Development Institute.
NCT06421935 is a Phase 1 study of Advanced Solid Tumor that is active but no longer recruiting, run by EMD Serono Research & Development Institute. The registered enrollment target is 141 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06421935, a Phase 1 study of Advanced Solid Tumor, is active but no longer recruiting, sponsored by EMD Serono Research & Development Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 141 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 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.
Conditions Studied
Interventions
- DRUG Abiraterone acetate
- DRUG M9466
- DRUG Tuvusertib
- DRUG Prednisone/Prednisolone
Study Locations (20)
Other
- Cancer Research SA - Adelaide
- GenesisCare North Shore (Oncology) - St Leonards
- Harasanshin Hospital - Fukuoka
- National Cancer Center Hospital East - Dept of Experimental Therapeutics - Kashiwa-shi
- Cancer Institute Hospital of JFCR - Kōtoku
- NHO Kumamoto Medical Center - Dept of Urology - Kumamoto
- Seoul National University Bundang Hospital - Seongnam
- Asan Medical Center - Seoul
- Samsung Medical Center - Seoul
- Seoul National University Hospital - Seoul
- Severance Hospital, Yonsei University Health System - Division of Infectious Diseases - Seoul
- Hospital HM Nou Delfos - START Barcelona - Barcelona
- Hospital Universitari Vall d'Hebron - Oncology Dept. - Barcelona
- ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia - Barcelona
- Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica - Madrid
- Hospital Universitario 12 de Octubre - Servicio de Oncologia - Madrid
- Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I - Madrid
- NEXT Madrid - Hospital Universitario Quironsalud Madrid - Pozuelo de Alarcón
New York
- NEXT Oncology - PARENT - New York
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2024-08-07 |
| Est. Completion | 2027-02-22 |
| Phase | Phase 1 |
What the registry record for NCT06421935 still lists
NCT06421935 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Abiraterone acetate is the first listed.
NCT06421935 names 20 study sites across 3 states, led by Other, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT06421935 about?
NCT06421935 is a clinical study titled "M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)". The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment...
What is the current status of trial NCT06421935?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 141 participants. The study started on 2024-08-07. Estimated completion is 2027-02-22.
What conditions does trial NCT06421935 study?
This clinical trial studies the following conditions: Advanced Solid Tumor.
What interventions are being tested in trial NCT06421935?
The interventions under investigation include: Abiraterone acetate (DRUG), M9466 (DRUG), Tuvusertib (DRUG), Prednisone/Prednisolone (DRUG).
Who is sponsoring clinical trial NCT06421935?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06421935 being conducted?
This trial has 20 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06421935's enrollment target sits among peer trials
141 94th of 189 higher than 95 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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