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NCT06509906 · ClinicalTrials.gov registry record · Phase 1
M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT06509906: Clinical Trial Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT06509906 is a Phase 1 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06509906, a Phase 1 study, was terminated before completion, sponsored by EMD Serono Research & Development Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens. As such the combination with FOLFIRI (folinic acid, fluorouracil, irinotecan) and Bevacizumab will be evaluated in participants with colorectal cancer, to establish the M9466 maximum tolerated dose if observed and the recommended dose for expansion. Study Duration: After a Screening period of up to 28 days, enrolled participants will remain in the study until they have completed all the study visits or until they withdraw consent, are lost to follow-up, or die. Visit Frequency: The participants will come for a Screening Visit and 1 to 2 visits per treatment cycle. After end of study intervention period, the participants will come for an End of Treatment Visit and a Safety Follow-up Visit.
Interventions
- DRUG Bevacizumab
- DRUG Irinotecan
- DRUG Fluorouracil (5-FU)
- DRUG M9466
- DRUG Folinic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2024-10-08 |
| Est. Completion | 2025-12-02 |
| Phase | Phase 1 |
Why NCT06509906 stopped before completion
NCT06509906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT06509906 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06509906 about?
NCT06509906 is a clinical study titled "M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)". The purpose of this study is to evaluate the safety and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens. As such the combination with FOLFIRI (folinic acid, fluorouracil, irinotecan) and Bevacizumab will be evaluated in participants with colorecta...
What is the current status of trial NCT06509906?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2024-10-08. Estimated completion is 2025-12-02.
What interventions are being tested in trial NCT06509906?
The interventions under investigation include: Bevacizumab (DRUG), Irinotecan (DRUG), Fluorouracil (5-FU) (DRUG), M9466 (DRUG), Folinic acid (DRUG).
Who is sponsoring clinical trial NCT06509906?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06509906's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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