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A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies
NCT04606381 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04606381
The ClinicalTrials.gov registry entry for NCT04606381 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04606381 reports 12 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04606381?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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