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

Titre officiel

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

Sommaire:

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.

Description de l'essai

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

• 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

Voir cet essai sur ClinicalTrials.gov