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ACTIVE NOT RECRUITING
NCT04606381
PHASE1

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Official title: An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Amivantamab, a Human Bispecific EGFR and cMet Antibody for the Treatment of Advanced Solid Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

158

Start Date

2020-11-10

Completion Date

2026-12-31

Last Updated

2026-03-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

Ami-LC-MD

Participants will receive amivantamab admixed with rHuPH20 SC infusion.

DRUG

Ami-LC

Participants will receive amivantamab SC infusion.

DRUG

Ami-HC

Participants will receive amivantamab SC infusion.

DRUG

Ami-HC-CF

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

Locations (12)

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