Study Stopped
N\~15 subjects data analysis did not meet statistical consideration of ORR and study primary/secondary objectives were not met. Enrollment was terminated for futility
A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma
A Phase 2, Open-Label Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma
2 other identifiers
interventional
18
1 country
13
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2022
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2022
CompletedStudy Start
First participant enrolled
December 8, 2022
CompletedFirst Posted
Study publicly available on registry
December 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2023
CompletedResults Posted
Study results publicly available
October 30, 2024
CompletedJanuary 13, 2025
January 1, 2025
10 months
December 8, 2022
October 7, 2024
January 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment
ORR was defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) as determined by investigator per RECIST version 1.1. As per RECIST version 1.1, CR was defined as disappearance of all extranodal lesions, the regression of all nodal lesions to less than (\<)10 millimeter (mm) short axis and the normalization of tumor marker level. PR was defined as greater than or equal to (\>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference baseline sum of diameters of target lesions.
From start of treatment on Day 1 up to 3.8 months
Secondary Outcomes (16)
Duration of Response (DOR) as Per RECIST Version 1.1
From the date of first documented response up to date of first documented PD or death (up to 3.8 months)
Disease Control Rate (DCR) as Per RECIST Version 1.1
From start of treatment on Day 1 up to 3.8 months
Progression Free Survival (PFS) as Per RECIST Version 1.1
From start of the treatment (Day 1) until disease progression or death (up to 3.8 months)
Overall Survival (OS)
From start of the treatment (Day 1) until death due to any cause (up to 3.8 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
From start of the treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy (up to 3.8 months)
- +11 more secondary outcomes
Study Arms (1)
Amivantamab Monotherapy
EXPERIMENTALParticipants 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.
Interventions
Amivantamab will be administered intravenously.
Eligibility Criteria
You may qualify if:
- Participant must have histologically or cytologically confirmed diagnosis of hepatocellular carcinoma (HCC) (fibrolamellar and mixed hepatocellular / cholangiocarcinoma subtypes are not eligible) based on pathology report, who have barcelona clinic liver cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
- Participant must have measurable disease according to response criteria in solid tumors (RECIST) Version 1.1. Selected target lesions must meet 1 of 2 criteria: 1) not previously treated with local therapy or 2) within the field of prior local therapy but with documented subsequent progression as per RECIST v1.1
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Participant must have adequate organ and bone marrow function
- A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Female participants should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility
You may not qualify if:
- Participants with prior liver transplant, history of hepatic encephalopathy, portal vein invasion at the main portal branch (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging, or any current moderate or severe ascites as measured by physical examination that requires active paracentesis for control due to the underlying HCC
- Participant has known allergies, hypersensitivity, or intolerance to excipients of amivantamab
- Other clinically active liver disease of infectious origin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Beijing Cancer Hospital
Beijing, 100142, China
The First Hospital of Jilin University
Chang Chun Shi, 130021, China
The Third Xiangya Hospital, Central South University
Changsha, 410013, China
West China Hospital
Chengdu, 610041, China
Chongqing Cancer Hospital
Chongqing, 400033, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, 116023, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, 350025, China
Nanfang Hospital
Guangzhou, 510515, China
Zhejiang University First Hospital
Hangzhou, 310003, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
The Second Affiliatde Hospital To Nanchang University
Nanchang, 330030, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030, China
Xi An International Medical Center Hospital
Xi'an, 710100, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Head Oncology
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2022
First Posted
December 16, 2022
Study Start
December 8, 2022
Primary Completion
October 10, 2023
Study Completion
October 10, 2023
Last Updated
January 13, 2025
Results First Posted
October 30, 2024
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu