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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06421935
The ClinicalTrials.gov registry entry for NCT06421935 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (27% lower). The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
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