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

NCT ID: NCT04606381

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-10
• Study Completion Date: 2026-12-31

Brief 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

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Ami-LC-MD and Ami-LC

Participants in cohort 1a will receive amivantamab admixed with rHuPH20 (Ami-LC-MD) subcutaneous (SC) infusion and participants in cohort 1b will receive amivantamab (Ami-LC) SC infusion.

Group Type: EXPERIMENTAL

Ami-LC-MD

Intervention Type: DRUG

Participants will receive amivantamab admixed with rHuPH20 SC infusion.

Ami-LC

Intervention Type: DRUG

Participants will receive amivantamab SC infusion.

Part 2: Ami-HC and Ami-HC-CF

Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF).

Group Type: EXPERIMENTAL

Ami-HC

Intervention Type: DRUG

Participants will receive amivantamab SC infusion.

Ami-HC-CF

Intervention Type: DRUG

Participants will receive amivantamab co-formulated with rHuPH20 as SC injection.

Interventions

Ami-LC-MD

Participants will receive amivantamab admixed with rHuPH20 SC infusion.

Intervention Type: DRUG

Ami-LC

Participants will receive amivantamab SC infusion.

Intervention Type: DRUG

Ami-HC

Participants will receive amivantamab SC infusion.

Intervention Type: DRUG

Ami-HC-CF

Participants will receive amivantamab co-formulated with rHuPH20 as SC injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Part 1 and Part 2: Participant must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and which may derive benefit from epidermal growth factor receptor (EGFR) or mesenchymal-epidermal transition tyrosine kinase receptor/hepatocyte growth factor receptor (cMet) directed therapy. Eligible tumor types include non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), hepatocellular cancer (HCC), colorectal cancer (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 therapy for metastatic disease, be ineligible for, or have refused all other currently available therapeutic options. In cases where participants refuse currently available therapeutic options, this must be documented in the study records.
• Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at Screening and a negative urine or serum pregnancy test within 24 hours before the first dose of study drug
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug
• A man who is sexually active with a woman of childbearing potential must agree to use a condom and his partner must also be practicing a highly effective method of contraception (that is, established use of oral, injected or implanted hormonal methods of contraception; placement of an Intrauterine device [IUD] or Intrauterine system [IUS])

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Cedars Sinai Medical Center

West Hollywood, California, United States

Community Health Network

Indianapolis, Indiana, United States

Langone Health at NYC University, NYU School of Medicine

New York, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

University Health Network

Toronto, Ontario, Canada

Chungbuk National University Hospital

Cheongju-si, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

The Christie Nhs Foundation Trust

Manchester, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

Countries

United States; Canada; South Korea; United Kingdom

Other Identifiers

61186372NSC1003

Identifier Type: OTHER

Identifier Source: secondary_id

2020-003225-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108891

Identifier Type: -

Identifier Source: org_study_id