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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04882917
The ClinicalTrials.gov registry entry for NCT04882917 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (89% lower). The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.
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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.