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

Official Title

An Open-label, Multicentre, 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


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.

Trial Description

Primary Outcome:

  • Observed Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough)
  • Number of Participants with Adverse Event (AE)
  • Number of Participants with Dose Limiting Toxicity (DLT)
  • Number of Participants with Clinical Laboratory Abnormalities
Secondary Outcome:
  • Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies
  • Epidermal Growth Factor Receptor (EGFR) Concentrations
  • Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers
  • Overall Response Rate (ORR)
  • Maximum Dosing Interval Between Time Zero to Steady State

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society