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

Last updated: March 29, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

Ami-HC-CF

Ami-HC

Ami-LC-MD

Clinical Study ID

NCT04606381
CR108891
2020-003225-36
61186372NSC1003
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Part 1 and Part 2: Participant must have histologically or cytologically confirmedsolid malignancy that is metastatic or unresectable and which may derive benefitfrom epidermal growth factor receptor (EGFR) or mesenchymal-epidermal transitiontyrosine kinase receptor/hepatocyte growth factor receptor (cMet) directed therapy.Eligible tumor types include non-small cell lung cancer (NSCLC), squamous cellcarcinoma of the head and neck (SCCHN), hepatocellular cancer (HCC), colorectalcancer (CRC), renal cell cancer (RCC), medullary thyroid cancer (MTC),gastroesophageal cancer (GEC), mesothelioma, breast cancer (BC) and ovarian cancer (OC). Participants must have either progressed after prior standard of care therapyfor metastatic disease, be ineligible for, or have refused all other currentlyavailable therapeutic options. In cases where participants refuse currentlyavailable therapeutic options, this must be documented in the study records; Part 3:Participants with histologically or cytologically confirmed NSCLC with previouslyidentified EGFR mutation (identified locally in a Clinical Laboratory ImprovementAmendments [CLIA]-certified laboratory [or equivalent]) that is metastatic orunresectable and have progressed on or after at least one line of standard of caresystemic treatment for metastatic disease. Required prior therapy includes anapproved anti-EGFR tyrosine kinase inhibitor (TKI), or in the case of EGFR exon 20insertion mutation disease, platinum-based chemotherapy. A participant who hasrefused all other currently available therapeutic options is allowed to enroll andmust be documented in the study records

  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance statusof 0 or 1

  • A woman of childbearing potential must have a negative serum (beta-human chorionicgonadotropin [beta-hCG]) at Screening and a negative urine or serum pregnancy testwithin 24 hours before the first dose of study drug

  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assistedreproduction during the study and for 6 months after receiving the last dose ofstudy drug

  • A man who is sexually active with a woman of childbearing potential must agree touse a condom and his partner must also be practicing a highly effective method ofcontraception (that is, established use of oral, injected or implanted hormonalmethods of contraception; placement of an Intrauterine device [IUD] or Intrauterinesystem [IUS])

Exclusion

Exclusion criteria:

  • Participant has uncontrolled inter-current illness, including but not limited topoorly controlled hypertension or diabetes, ongoing or active systemic infection (that is, has discontinued all antibiotics for at least one week prior to first doseof study drug), diagnosed or suspected viral infection (except Humanimmunodeficiency virus [HIV] positive participants with 1 or more of the following:a) not receiving highly active antiretroviral therapy; b) a change in antiretroviraltherapy 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 6months of the start of screening), or psychiatric illness/social situation thatwould limit compliance with study requirements, including ability to self-care foranticipated toxicities [that is. rash or paronychia]. Participants with medicalconditions requiring chronic continuous oxygen therapy are excluded

  • Participant has had prior chemotherapy, targeted cancer therapy, or treatment withan investigational anti-cancer agent within 2 weeks or 4 half-lives, whichever islonger, before the first administration of study drug; or participant has receivedprior 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 4weeks. Toxicities from previous anticancer therapies should have resolved tobaseline levels or to Grade 1 or less, (except for alopecia [any grade], Grade lessthan or equal to [<=] 2 peripheral neuropathy, and Grade less than [<] 2hypothyroidism stable on hormone replacement). Autoimmune toxicities from previousimmunotherapy must be fully resolved to baseline levels

  • Participants with untreated brain metastases. Participants with locally treatedmetastases that are clinically stable and asymptomatic for at least 2 weeks and whoare 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 requiringtreatment

  • Participant has leptomeningeal disease

Study Design

Total Participants: 159
Treatment Group(s): 5
Primary Treatment: Ami-HC-CF
Phase: 1
Study Start date:
November 10, 2020
Estimated Completion Date:
October 21, 2025

Connect with a study center

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • University Health Network

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si, 28644
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • The Christie Nhs Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • Cedars Sinai Medical Center

    West Hollywood, California 90048
    United States

    Site Not Available

  • Community Health Network

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Langone Health at NYC University, NYU School of Medicine

    New York, New York 10016
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

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