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NCT03225105 · ClinicalTrials.gov registry record · Phase 1
M3541 in Combination With Radiotherapy in Solid Tumors
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03225105: Clinical Trial Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT03225105 is a Phase 1 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03225105, a Phase 1 study, was terminated before completion, sponsored by EMD Serono Research & Development Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This dose-escalation study evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and explore antitumor activity of M3541 in combination with fractionated palliative radiotherapy (RT) in participants with solid tumors with malignant lesions in the thorax, abdominal cavity, head and neck region, or extremities likely to benefit from palliative RT.
Primary Outcome
DLT is classified per the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and defined as any of the following events occurring after first dose of study intervention and judged not to be related to underlying disease or any previous or concomitant medication. Grade (Gr) \>=3 non-hematologic toxicity with exception of Nausea, vomiting and diarrhea lasting =\<3 days in once per FD; Worsening of preexisting tumor pain associated with tumor lesions for which participant was irrad
Interventions
- DRUG M3541
- RADIATION Palliative Radiotherapy (RT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-09-06 |
| Est. Completion | 2020-04-27 |
| Phase | Phase 1 |
Why NCT03225105 stopped before completion
NCT03225105 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which M3541 is the first listed.
NCT03225105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03225105 about?
NCT03225105 is a clinical study titled "M3541 in Combination With Radiotherapy in Solid Tumors". This dose-escalation study evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and explore antitumor activity of M3541 in combination with fractionated palliative radiotherapy (RT) in participants with solid tumors with malignant lesions in the thorax, abdominal cavity, head a...
What is the current status of trial NCT03225105?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-09-06. Estimated completion is 2020-04-27.
What interventions are being tested in trial NCT03225105?
The interventions under investigation include: M3541 (DRUG), Palliative Radiotherapy (RT) (RADIATION).
Who is sponsoring clinical trial NCT03225105?
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 NCT03225105's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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