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NCT04457778 · ClinicalTrials.gov registry record · Phase 1
First in Human Study of M6223
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT04457778: Completed Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT04457778 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04457778, a Phase 1 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), immunogenicity and (if observed) the maximum tolerated dose (MTD) of M6223 as a single agent (Part 1A) for both the every 2 weeks (Q2W) regimen and the every 3 weeks (Q3W) regimen and of M6223 combined with bintrafusp alfa (Part 1B) for Q2W regimen in participants with metastatic or locally advanced solid unresectable tumors.
Primary Outcome
A DLT is defined as any Grade ≥ 3 non-hematologic AE or any Grade ≥ 4 hematologic AE according to the NCI-CTCAE, occurring during the DLT observation period (28 days from first administration of study intervention) that is not clearly related to the underlying disease or any previous or concomitant medication, concomitant disease or unrelated illness. A DLT must be confirmed by the Safety Monitoring Committee. DLT is considered if the following related AEs occur: • Grade ≥ 3 neutropenia with cli
Interventions
- DRUG M6223
- DRUG Bintrafusp alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-07-10 |
| Est. Completion | 2023-06-23 |
| Phase | Phase 1 |
What the finished NCT04457778 record still lists
NCT04457778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which M6223 is the first listed.
NCT04457778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04457778 about?
NCT04457778 is a clinical study titled "First in Human Study of M6223". The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), immunogenicity and (if observed) the maximum tolerated dose (MTD) of M6223 as a single agent (Part 1A) for both the every 2 weeks (Q2W) regimen and the every 3 weeks (Q3W) regimen and of M6223 combined w...
What is the current status of trial NCT04457778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2020-07-10. Estimated completion is 2023-06-23.
What interventions are being tested in trial NCT04457778?
The interventions under investigation include: M6223 (DRUG), Bintrafusp alfa (DRUG).
Who is sponsoring clinical trial NCT04457778?
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 NCT04457778's enrollment target sits among peer trials
58 895th of 2000 higher than 1,100 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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