Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 58 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04457778
The ClinicalTrials.gov registry entry for NCT04457778 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which M6223 is the first listed.
NCT04457778 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.