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NCT03306420 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study of MS201408-0005A as Single Agent and in Combinations
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03306420: Clinical Trial Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT03306420 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
NCT03306420, 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 is a Phase I, open-label study to determine the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and preliminary antitumor activity of MS201408-0005A as single agent (Part IA only) and in combination with MS201408-0005C or MS201408-0005B (Part IB, Part IC).
Primary Outcome
DLTs was assessed as per NCI CTCAE v 4.03. DLT defined as any Grade greater than or equal (\>=) 3 nonhematological AE or Immune-related adverse event (irAE) assessed by Investigator or Sponsor during first Cycle (first 28 days) of study treatment. Asymptomatic Grade \>= 3 lipase or amylase elevation not associated with clinical manifestations of pancreatitis. Any TEAE observed in subsequent cycle. Any Grade 4 neutropenia of \>= 5 days duration, Grade \>= 3 febrile neutropenia, Grade 3 hemoglobin
Interventions
- DRUG M4112
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-10-03 |
| Est. Completion | 2019-01-14 |
| Phase | Phase 1 |
Why NCT03306420 stopped before completion
NCT03306420 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 1 intervention - of which M4112 is the first listed.
NCT03306420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03306420 about?
NCT03306420 is a clinical study titled "First-in-Human Study of MS201408-0005A as Single Agent and in Combinations". This is a Phase I, open-label study to determine the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and preliminary antitumor activity of MS201408-0005A as single agent (Part IA only) and in combination with MS201408-0005C or MS201408-0005B (Part IB, Part IC).
What is the current status of trial NCT03306420?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-10-03. Estimated completion is 2019-01-14.
What interventions are being tested in trial NCT03306420?
The interventions under investigation include: M4112 (DRUG).
Who is sponsoring clinical trial NCT03306420?
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 NCT03306420'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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