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NCT04606381 · ClinicalTrials.gov registry record · Phase 1
A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies
A Phase 1 study of Neoplasms, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 1
- Development phase
- 158
- Enrollment target
- 12
- Study locations
NCT04606381: Active Phase 1 study of Neoplasms, sponsored by Janssen Research & Development.
NCT04606381 is a Phase 1 study of Neoplasms that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 158 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (90% lower). The trial reports 12 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04606381, a Phase 1 study of Neoplasms, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 158 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.
Primary Outcome
Ctrough is the observed amivantamab serum concentration immediately prior to the next drug administration.
Conditions Studied
Interventions
- DRUG Ami-LC-MD
- DRUG Ami-LC
- DRUG Ami-HC
- DRUG Ami-HC-CF
Study Locations (12)
Other
- Chungbuk National University Hospital - Cheongju-si
- Seoul National University Bundang Hospital - Seongnam-si
- Severance Hospital Yonsei University Health System - Seoul
- Samsung Medical Center - Seoul
- The Christie Nhs Foundation Trust - Manchester
- Royal Marsden Hospital - Sutton
California
- Cedars Sinai Medical Center - West Hollywood
Indiana
- Community Health Network - Indianapolis
New York
- Langone Health at NYC University, NYU School of Medicine - New York
Oregon
- Providence Portland Medical Center - Portland
Tennessee
- Sarah Cannon Research Institute - Nashville
Ontario
- University Health Network - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2020-11-10 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04606381 still lists
NCT04606381 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Ami-LC-MD is the first listed.
NCT04606381 lists 12 locations in 7 states (Other, California, Indiana).
Frequently Asked Questions
What is clinical trial NCT04606381 about?
NCT04606381 is a clinical study titled "A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies". The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.
What is the current status of trial NCT04606381?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 158 participants. The study started on 2020-11-10. Estimated completion is 2026-12-31.
What conditions does trial NCT04606381 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT04606381?
The interventions under investigation include: Ami-LC-MD (DRUG), Ami-LC (DRUG), Ami-HC (DRUG), Ami-HC-CF (DRUG).
Who is sponsoring clinical trial NCT04606381?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04606381 being conducted?
This trial has 12 study locations across California, Indiana, New York, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04606381's enrollment target sits among peer trials
158 53rd of 158 higher than 106 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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.
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