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NCT02517398 · ClinicalTrials.gov registry record · Phase 1
MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 600
- Enrollment target
NCT02517398: Completed Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT02517398 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 600 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (900% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02517398, a Phase 1 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 600 participants
- Enrollment target
Study Summary
The main purpose of this Phase I study was to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.
Primary Outcome
Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE w
Interventions
- DRUG MSB0011359C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2015-08-31 |
| Est. Completion | 2022-05-23 |
| Phase | Phase 1 |
What the finished NCT02517398 record still lists
NCT02517398 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (900% higher).
The record links to 0 conditions, and to 1 intervention - of which MSB0011359C is the first listed.
NCT02517398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02517398 about?
NCT02517398 is a clinical study titled "MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors". The main purpose of this Phase I study was to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although i...
What is the current status of trial NCT02517398?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 600 participants. The study started on 2015-08-31. Estimated completion is 2022-05-23.
What interventions are being tested in trial NCT02517398?
The interventions under investigation include: MSB0011359C (DRUG).
Who is sponsoring clinical trial NCT02517398?
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 NCT02517398's enrollment target sits among peer trials
600 27th of 2000 higher than 1,973 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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