A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05653427
Phase
PHASE2
Status
Terminated

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amivantamab — DRUG
    Amivantamab will be administered intravenously.

Study Details

The purpose of this study is to characterize the preliminary antitumor activity of amivantamab at the recommended dose in participants with previously systemically treated hepatocellular carcinoma (HCC)

Key Dates

Start date
Dec 8, 2022
Status verified
Jan 2025
Primary completion
Oct 10, 2023
Completion
Oct 10, 2023

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Amivantamab Monotherapy
    Participants will receive amivantamab monotherapy intravenously once weekly on Days 1 and 2 in Cycle 1 and on Days 1 and 15 from Cycle 2 onwards based on body weight. Each cycle is of 28 days.

Primary Outcome Measure

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment [ Time Frame: From start of treatment on Day 1 up to 3.8 months ]

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