🏛️ Verified NIH Record • Updated 2026-08-27

A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (NCT04606381)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (6 items).

Location: Cedars Sinai Medical Center — West Hollywood, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion criteria:
  • Participant has uncontrolled inter-current illness, including but not limited to poorly controlled hypertension or diabetes, ongoing or active systemic infection (that is, has discontinued all antibiotics for at least one week prior to first dose of study drug), diagnosed or suspected viral infection (except Human immunodeficiency virus \[HIV\] positive participants with 1 or more of the following: a) not receiving highly active antiretroviral therapy; b) a change in antiretroviral therapy within 6 months of the start of screening; c) cluster of differentiation 4 (CD4)+ T-cell count less than \[\<\]350 per cubic millimeters \[mm\^3\] at screening; d) an acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening), or psychiatric illness/social situation that would limit compliance with study requirements, including ability to self-care for anticipated toxicities \[that is. rash or paronychia\]. Participants with medical conditions requiring chronic continuous oxygen therapy are excluded
  • Participant has had prior chemotherapy, targeted cancer therapy, or treatment with an investigational anti-cancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study drug; or participant has received prior immunotherapy within 6 weeks before the first administration of study drug. For agents with long half-lives, the maximum required time since last dose is 4 weeks. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less, (except for alopecia \[any grade\], Grade less than or equal to \[\<=\] 2 peripheral neuropathy, and Grade less than \[\<\] 2 hypothyroidism stable on hormone replacement). Autoimmune toxicities from previous immunotherapy must be fully resolved to baseline levels
  • Participants with untreated brain metastases. Participants with locally treated metastases that are clinically stable and asymptomatic for at least 2 weeks and who are off or receiving low-dose corticosteroid treatment (\<=10 milligrams \[mg\] prednisone or equivalent) for at least 2 weeks prior to study treatment are eligible
  • Participant has an active malignancy other than the disease under study requiring treatment
  • Participant has leptomeningeal disease

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (12 Sites)

  • Cedars Sinai Medical Center — West Hollywood, California
  • Community Health Network — Indianapolis, Indiana
  • Langone Health at NYC University, NYU School of Medicine — New York, New York
  • Providence Portland Medical Center — Portland, Oregon
  • Sarah Cannon Research Institute — Nashville, Tennessee
  • University Health Network — Toronto, Ontario
  • 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,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗