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

NCT04606381 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2026-05-08

No results posted yet for this 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.

Conditions

  • Neoplasms

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2024-07-11
Completion
2027-04-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • South Korea
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04606381 on ClinicalTrials.gov