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

Primary Purpose

Carcinoma, Hepatocellular

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Amivantamab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary Other clinically active liver disease of infectious origin Participant has a history of clinically significant cardiovascular disease including, but not limited to: a. diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study treatment or any of the following within 6 months prior to the first dose of study treatment: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as nonobstructive catheter-associated clots, are not exclusionary; b. prolonged corrected QT interval using Fridericia's formula (QTcF) greater than (>)480 millisecond (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); c. uncontrolled (persistent) hypertension: systolic blood pressure >160 mm Hg; diastolic blood pressure >100 millimeter of mercury (mm Hg), or congestive heart failure (CHF) defined as New York Heart Association (NYHA) class III/IV or hospitalization for CHF (any NYHA class) within 6 months of study enrollment; d. pericarditis/clinically significant pericardial effusion; e. myocarditis

Sites / Locations

  • Beijing Cancer HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • The Third Xiangya Hospital, Central South UniversityRecruiting
  • West China HospitalRecruiting
  • Chongqing Cancer HospitalRecruiting
  • The Second Affiliated Hospital of Dalian Medical UniversityRecruiting
  • Mengchao Hepatobiliary Hospital of Fujian Medical UniversityRecruiting
  • Nanfang HospitalRecruiting
  • Zhejiang University First HospitalRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • The Second Affiliatde Hospital To Nanchang UniversityRecruiting
  • Union Hospital Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
  • Xi'An International Medical Center HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amivantamab Monotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieve either partial response (PR) or complete response (CR), determined by investigator assessment using response criteria in solid tumors (RECIST) Version 1.1.

Secondary Outcome Measures

Duration of Response (DOR)
DoR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first.
Disease Control Rate (DCR)
DCR is defined as the percentage of participants achieving complete or partial response or stable disease of at least 11 weeks as defined by RECIST Version 1.1.
Progression-free Survival (PFS)
PFS is defined as the time from the date the first dose until the date of objective disease progression or death by any cause, whichever comes first, based on investigator review according to RECIST Version 1.1.
Overall Survival (OS)
OS is defined as the time from the date of the first dose until the date of death due to any cause.
Number of Participants with of Adverse Events
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Number of Participants with Abnormalities in Clinical Laboratory Assessments
Number of participants with abnormalities in clinical laboratory tests including serum chemistry and hematology) will be reported.
Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs (including temperature, pulse/heart rate, and blood pressure) will be reported.
Maximum Serum Concentration (Cmax) of Amivantamab
Cmax is defined as maximum serum concentration of amivantamab.
Time to Reach Maximum Serum Concentration (Tmax) of Amivantamab
Tmax is defined as time to reach maximum serum concentration of amivantamab.
Area Under the Serum Concentration-time Curve of Amivantamab from Time t1 to t2 (AUC[t1-t2])
AUC(t1-t2) is defined as the area under the serum concentration-time curve of amivantamab from time t1 to t2.
Area Under the Concentration-time Curve of Amivantamab From Time Zero to End of Dosing Interval (AUCtau)
AUCtau is the measure of the serum drug concentration of amivantamab from time zero to end of dosing interval.
Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) of Amivantamab
Ctrough is defined as serum concentration immediately prior to the next dose administration (Ctrough) of amivantamab.
Accumulation Ratio (R)
R is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose.
Number of Participants with Anti-amivantamab Antibodies
Number of participants with anti-amivantamab antibodies will be reported.

Full Information

First Posted
December 8, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05653427
Brief Title
A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma
Official Title
A Phase 2, Open-Label Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
February 9, 2024 (Anticipated)
Study Completion Date
October 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amivantamab Monotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Amivantamab
Other Intervention Name(s)
JNJ-61186372
Intervention Description
Amivantamab will be administered intravenously.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants who achieve either partial response (PR) or complete response (CR), determined by investigator assessment using response criteria in solid tumors (RECIST) Version 1.1.
Time Frame
Up to 1 year 10 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
DoR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first.
Time Frame
Up to 1 year 10 months
Title
Disease Control Rate (DCR)
Description
DCR is defined as the percentage of participants achieving complete or partial response or stable disease of at least 11 weeks as defined by RECIST Version 1.1.
Time Frame
Up to 1 year 10 months
Title
Progression-free Survival (PFS)
Description
PFS is defined as the time from the date the first dose until the date of objective disease progression or death by any cause, whichever comes first, based on investigator review according to RECIST Version 1.1.
Time Frame
Up to 1 year 10 months
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of the first dose until the date of death due to any cause.
Time Frame
Up to 1 year 10 months
Title
Number of Participants with of Adverse Events
Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time Frame
Up to 1 year 10 months
Title
Number of Participants with Abnormalities in Clinical Laboratory Assessments
Description
Number of participants with abnormalities in clinical laboratory tests including serum chemistry and hematology) will be reported.
Time Frame
Up to 1 year 10 months
Title
Number of Participants with Abnormalities in Vital Signs
Description
Number of participants with abnormalities in vital signs (including temperature, pulse/heart rate, and blood pressure) will be reported.
Time Frame
Up to 1 year 10 months
Title
Maximum Serum Concentration (Cmax) of Amivantamab
Description
Cmax is defined as maximum serum concentration of amivantamab.
Time Frame
Up to 1 year 10 months
Title
Time to Reach Maximum Serum Concentration (Tmax) of Amivantamab
Description
Tmax is defined as time to reach maximum serum concentration of amivantamab.
Time Frame
Up to 1 year 10 months
Title
Area Under the Serum Concentration-time Curve of Amivantamab from Time t1 to t2 (AUC[t1-t2])
Description
AUC(t1-t2) is defined as the area under the serum concentration-time curve of amivantamab from time t1 to t2.
Time Frame
Up to 1 year 10 months
Title
Area Under the Concentration-time Curve of Amivantamab From Time Zero to End of Dosing Interval (AUCtau)
Description
AUCtau is the measure of the serum drug concentration of amivantamab from time zero to end of dosing interval.
Time Frame
Up to 1 year 10 months
Title
Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) of Amivantamab
Description
Ctrough is defined as serum concentration immediately prior to the next dose administration (Ctrough) of amivantamab.
Time Frame
Up to 1 year 10 months
Title
Accumulation Ratio (R)
Description
R is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose.
Time Frame
Up to 1 year 10 months
Title
Number of Participants with Anti-amivantamab Antibodies
Description
Number of participants with anti-amivantamab antibodies will be reported.
Time Frame
Up to 1 year 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary Other clinically active liver disease of infectious origin Participant has a history of clinically significant cardiovascular disease including, but not limited to: a. diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study treatment or any of the following within 6 months prior to the first dose of study treatment: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as nonobstructive catheter-associated clots, are not exclusionary; b. prolonged corrected QT interval using Fridericia's formula (QTcF) greater than (>)480 millisecond (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); c. uncontrolled (persistent) hypertension: systolic blood pressure >160 mm Hg; diastolic blood pressure >100 millimeter of mercury (mm Hg), or congestive heart failure (CHF) defined as New York Heart Association (NYHA) class III/IV or hospitalization for CHF (any NYHA class) within 6 months of study enrollment; d. pericarditis/clinically significant pericardial effusion; e. myocarditis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Chang Chun Shi
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Xiangya Hospital, Central South University
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing Cancer Hospital
City
Chong Qing
ZIP/Postal Code
400033
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Dalian Medical University
City
Dalian
ZIP/Postal Code
116023
Country
China
Individual Site Status
Recruiting
Facility Name
Mengchao Hepatobiliary Hospital of Fujian Medical University
City
Fu Zhou Shi
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Name
Nanfang Hospital
City
Guang Zhou Shi
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang University First Hospital
City
Hang Zhou Shi
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliatde Hospital To Nanchang University
City
Nan Chang Shi
ZIP/Postal Code
330030
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Xi'An International Medical Center Hospital
City
Xi'an
ZIP/Postal Code
710100
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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