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NCT04882917 · ClinicalTrials.gov registry record · Phase 1
First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)
A Phase 1 study of Advanced Solid Tumors, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 3
- Study locations
NCT04882917: Completed Phase 1 study of Advanced Solid Tumors, sponsored by EMD Serono Research & Development Institute.
NCT04882917 is a Phase 1 study of Advanced Solid Tumors that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 22 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (89% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04882917, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumors in dose escalation (Part 1A). Once the recommended dose for expansion (RDE) was declared in Part 1A, a preliminary food effect cohort, Part 1B, will follow at the RDE determined from Part 1A.
Primary Outcome
A DLT was defined as the occurrence of any of following events that were judged by the study investigator, received at least 80% of the planned cumulative dose during the DLT period of each study intervention and completed the DLT period or additionally, participants who did not receive 80% of the planned total dose of study intervention, but at least 80% dosing of a different dose cohort and finished the DLT period are eligible for the DLT analysis set to be analyzed in the highest dose cohort
Conditions Studied
Interventions
- DRUG M4076
Study Locations (3)
Texas
- MD Anderson Center - Houston
- NEXT Oncology - San Antonio
Ontario
- Princess Margaret Cancer Centre - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-05-24 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 1 |
What the finished NCT04882917 record still lists
NCT04882917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which M4076 is the first listed.
NCT04882917 reports a single indexed study location in Texas, Ontario.
Frequently Asked Questions
What is clinical trial NCT04882917 about?
NCT04882917 is a clinical study titled "First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)". The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumors in dose escalation (Part 1A). Once the recommended dose for ...
What is the current status of trial NCT04882917?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2021-05-24. Estimated completion is 2023-03-31.
What conditions does trial NCT04882917 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT04882917?
The interventions under investigation include: M4076 (DRUG).
Who is sponsoring clinical trial NCT04882917?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04882917 being conducted?
This trial has 3 study locations across Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04882917's enrollment target sits among peer trials
22 126th of 144 higher than 19 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors 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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