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NCT05198349 · ClinicalTrials.gov registry record · Phase 1
First in Human Study of M1069 in Advanced Solid Tumors
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT05198349: Clinical Trial Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT05198349 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
NCT05198349, 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
The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and early signs of efficacy of M1069 in participants with advanced solid malignancies.
Primary Outcome
A DLT was defined as any AE, per National Cancer Institute - Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0), assessed by the Investigator or Sponsor at any dose, unrelated to underlying disease, prior/concomitant medication, or condition, occurring during the DLT observation period. DLTs included Grade more than equal to (≥) 3 thrombocytopenia with bleeding, excluding isolated Grade 4 lymphopenia without symptoms or Grade 4 neutropenia/thrombocytopenia less than (\<
Interventions
- DRUG M1069
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-03-02 |
| Est. Completion | 2023-08-10 |
| Phase | Phase 1 |
Why NCT05198349 stopped before completion
NCT05198349 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 M1069 is the first listed.
NCT05198349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05198349 about?
NCT05198349 is a clinical study titled "First in Human Study of M1069 in Advanced Solid Tumors". The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and early signs of efficacy of M1069 in participants with advanced solid malignancies.
What is the current status of trial NCT05198349?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-03-02. Estimated completion is 2023-08-10.
What interventions are being tested in trial NCT05198349?
The interventions under investigation include: M1069 (DRUG).
Who is sponsoring clinical trial NCT05198349?
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 NCT05198349'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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