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

NCT04606381 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: CR10889161186372NSC10032020-003225-36
• Study Type: interventional
• Target: 158
• Locations: 4 countries
• Sites: 12

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

Keywords

Amivantamab; JNJ-61186372

Outcome Measures

Primary Outcomes (4)

• Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough)

  Ctrough is the observed amivantamab serum concentration immediately prior to the next drug administration.

  Up to Day 29

• Number of Participants with Adverse Event (AE)

  An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.

  Up to 4 years 1 month

• Number of Participants with Dose Limiting Toxicity (DLT)

  Number of participants with DLT will be assessed.

  Up to Day 28

• Number of Participants with Clinical Laboratory Abnormalities

  Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.

  Up to 4 years 1 month

Secondary Outcomes (5)

• Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies

  Up to 4 years 1 month

• Epidermal Growth Factor Receptor (EGFR) Concentrations

  Up to 4 years 1 month

• Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers

  Up to 4 years 1 month

• Overall Response Rate (ORR)

  Up to 4 years 1 month

• Part 2: Maximum Amivantamab Dosing Interval Between Time Zero to Steady State

  Up to 4 years 1 month

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Ami-LC-MD; Drug: Ami-LC

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

EXPERIMENTAL

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).

Drug: Ami-HC; Drug: Ami-HC-CF

Interventions

Ami-LC-MD DRUG

Participants will receive amivantamab admixed with rHuPH20 SC infusion.

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

Ami-LC DRUG

Participants will receive amivantamab SC infusion.

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

Ami-HC-CF DRUG

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

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

Ami-HC DRUG

Participants will receive amivantamab SC infusion.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[IUS\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (12)

Cedars Sinai Medical Center

West Hollywood, California, 90048, United States

Location

Community Health Network

Indianapolis, Indiana, 46256, United States

Location

Langone Health at NYC University, NYU School of Medicine

New York, New York, 10016, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Christie Nhs Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 28, 2020
• Study Start: November 10, 2020
• Primary Completion: July 11, 2024
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1); KR (4); GB (2); US (5)