Trial Outcomes & Findings for A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma (NCT NCT05653427)

Last Updated: 2025-01-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

From start of treatment on Day 1 up to 3.8 months

Results posted on

2025-01-13

Participant Flow

The study was planned to be conducted in 3 parts: Part 1, main Part 2 and expansion Part 3. However, due to the early termination of study, the enrollment was discontinued before planned enrollment was achieved in Part 2. Due to changes in the planned analysis, efficacy and safety data were analyzed together for Part 1 and Part 2 and Part 3 was not conducted. As a result, combined results for both parts were presented.

Participant milestones

Participant milestones
Measure	Amivantamab Monotherapy (1050/1400 mg) Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Overall Study STARTED	18
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Amivantamab Monotherapy (1050/1400 mg) Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Overall Study Study Terminated by Sponsor	13

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amivantamab Monotherapy (1050/1400 mg) n=18 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	49.9 Years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment CHINA	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment on Day 1 up to 3.8 months

Population: Response evaluable analysis set included all participants who received at least 1 dose of study treatment; had at least 1 post-baseline efficacy disease assessment, or discontinued treatment for any reason, or had disease progression/death prior to the first post-baseline disease assessment.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=18 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment	0.0 Percentage of participants Interval 0.0 to 18.5

SECONDARY outcome

Timeframe: From the date of first documented response up to date of first documented PD or death (up to 3.8 months)

DOR was defined as time from date of first documented response (CR/PR) until date of first documented progressive disease (PD) or death, whichever occurred first. As per RECIST version 1.1, CR was defined as disappearance of all extranodal lesions, the regression of all nodal lesions to \<10 mm short axis and the normalization of tumor marker level. PR was defined as \>=30% decrease in the sum of diameters of target lesions, taking as reference baseline sum of diameters of target lesions. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. There was no participant who had event (CR/PR), hence data could not be collected and analyzed for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment on Day 1 up to 3.8 months

DCR was defined as the percentage of participants achieving CR or PR or stable disease (SD) for at least 11 weeks as defined by 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 \<10 mm short axis and the normalization of tumor marker level. PR was defined as \>=30% decrease in the sum of diameters of target lesions, taking as reference baseline sum of diameters of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=18 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Disease Control Rate (DCR) as Per RECIST Version 1.1	0.0 Percentage of participants Interval 0.0 to 18.5

SECONDARY outcome

Timeframe: From start of the treatment (Day 1) until disease progression or death (up to 3.8 months)

PFS was defined as the time from the date of first dose of study drug until the date of objective disease progression or death by any cause, whichever comes first, based on investigator assessment using RECIST Version 1.1. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=18 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Progression Free Survival (PFS) as Per RECIST Version 1.1	1.48 Months Interval 1.41 to 1.51

SECONDARY outcome

Timeframe: From start of the treatment (Day 1) until death due to any cause (up to 3.8 months)

OS was defined as the time from the date of first dose of study drug until the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=18 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Overall Survival (OS)	NA Months Interval 3.84 to Here, 'NA' signifies that median and upper limit of 95% confidence interval (CI) could not be calculated due to less number of participants with events.

SECONDARY outcome

Timeframe: 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)

Population: All treated analysis set included all participants who received at least 1 dose of study treatment.

An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as AEs occurring at or after first dose of study drug up to 30 days after last dose or until the start of new anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE version 5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. All TEAEs including serious and non-serious events were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=18 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
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 Grade 1	5 Participants
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 Grade 2	9 Participants
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 Grade 3	3 Participants
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 Grade 4	0 Participants
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 Grade 5	1 Participants

SECONDARY outcome

Timeframe: 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)

Population: All treated analysis set included all participants who received at least 1 dose of study treatment.

Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry and hematology) were reported. Clinically significant abnormalities were determined based on investigator's discretion.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=18 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters	3 Participants

SECONDARY outcome

Timeframe: 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)

Population: All treated analysis set included all participants who received at least 1 dose of study treatment.

Vital signs assessments included systolic and diastolic blood pressure, heart rate, respiratory rate, pulse rate, body temperature and oxygen saturation. These measurements were taken after the participants had rested for at least 5 minutes in a quiet setting without distractions. Clinical significance of any vital signs was determined based on investigator's discretion.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=18 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Number of Participants With Clinically Significant Abnormalities in Vital Signs Values	0 Participants

SECONDARY outcome

Timeframe: Pre-dose, 0, 24, 26, 30, 48, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 6, 24, 72, 168, 240 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)

Population: Pharmacokinetics (PK) analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable postbaseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure and 'n' (number analyzed) refers to the participants evaluable at specified time points.

Cmax was defined as the maximum observed serum concentration of amivantamab. The concentrations of amivantamab were measured using a validated, specific, and sensitive enzyme-linked immunosorbent assay (ELISA) method.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=5 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Maximum Observed Serum Concentration (Cmax) of Amivantamab Cycle 1 Day 1	339 Micrograms per milliliter (mcg/mL) Standard Deviation 57.0
Maximum Observed Serum Concentration (Cmax) of Amivantamab Cycle 2 Day 1	711 Micrograms per milliliter (mcg/mL) Standard Deviation 79.0

SECONDARY outcome

Timeframe: Pre-dose, 0, 24, 26, 30, 48, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 6, 24, 72, 168, 240 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)

Population: PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable postbaseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure and 'n' (number analyzed) refers to the participants evaluable at specified time points.

Tmax was defined as the time to reach maximum observed serum concentration of amivantamab. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=5 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Time to Reach Maximum Observed Serum Concentration (Tmax) of Amivantamab Cycle 1 Day 1	27.18 Hours Interval 25.68 to 28.7
Time to Reach Maximum Observed Serum Concentration (Tmax) of Amivantamab Cycle 2 Day 1	5.87 Hours Interval 2.27 to 7.75

SECONDARY outcome

Timeframe: Pre-dose, 0, 24, 26, 30, 48, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 6, 24, 72 and 168 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)

AUC (0-168h) was defined as area under the serum concentration time-curve from time zero to the time point 168 hours. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=5 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Area Under the Serum Concentration Time Curve From Time Zero to Time 168 Hours (h) (AUC [0-168h]) of Amivantamab Cycle 1 Day 1	29084 microgramshours/milliliter (mcghr/mL) Standard Deviation 3772
Area Under the Serum Concentration Time Curve From Time Zero to Time 168 Hours (h) (AUC [0-168h]) of Amivantamab Cycle 2 Day 1	80434 microgramshours/milliliter (mcghr/mL) Standard Deviation 11319

SECONDARY outcome

Timeframe: Pre-dose, 0, 2, 6, 24, 72, 168, 240 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)

Area under the serum concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval of 336 hours was reported. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=3 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Area Under the Serum Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Amivantamab	117913 mcg*hr/mL Standard Deviation 19426

SECONDARY outcome

Timeframe: Pre-dose at 0 hour: Days 8 and 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 4; Day 15 of Cycle 2 and Cycle 3 (each cycle was of 28 days)

Ctrough of amivantamab at pre-dose on Days 8 and 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 4; Day 15 of Cycle 2 and Cycle 3 were reported. Ctrough was defined as pre-dose serum drug concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=17 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Serum Trough Concentrations (Ctrough) of Amivantamab: on Days 8 and 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 4; Day 15 of Cycle 2 and Cycle 3 Pre-dose Cycle 1 Day 8	145 mcg/mL Standard Deviation 103
Serum Trough Concentrations (Ctrough) of Amivantamab: on Days 8 and 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 4; Day 15 of Cycle 2 and Cycle 3 Pre-dose Cycle 1 Day 15	229 mcg/mL Standard Deviation 117
Serum Trough Concentrations (Ctrough) of Amivantamab: on Days 8 and 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 4; Day 15 of Cycle 2 and Cycle 3 Pre-dose Cycle 2 Day 1	326 mcg/mL Standard Deviation 76.0
Serum Trough Concentrations (Ctrough) of Amivantamab: on Days 8 and 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 4; Day 15 of Cycle 2 and Cycle 3 Pre-dose Cycle 2 Day 15	216 mcg/mL Standard Deviation 71.3
Serum Trough Concentrations (Ctrough) of Amivantamab: on Days 8 and 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 4; Day 15 of Cycle 2 and Cycle 3 Pre-dose Cycle 3 Day 15	87.7 mcg/mL Standard Deviation NA Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.
Serum Trough Concentrations (Ctrough) of Amivantamab: on Days 8 and 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 4; Day 15 of Cycle 2 and Cycle 3 Pre-dose Cycle 4 Day 1	87.6 mcg/mL Standard Deviation NA Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.

SECONDARY outcome

Timeframe: Pre-dose at 0 hour on Day 1 of Cycle 3 (each cycle was of 28 days)

Ctrough of amivantamab at pre-dose on Day 1 of Cycle 3 were reported. Ctrough was defined as pre-dose serum drug concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. As per change in planned analysis, data was not summarized for timepoint where number of participants analyzed were less than 3. Only individual participant data was available and reported.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=2 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Serum Trough Concentrations (Ctrough) of Amivantamab: on Day 1 of Cycle 3 Participant 1	104 mcg/mL Standard Deviation NA Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.
Serum Trough Concentrations (Ctrough) of Amivantamab: on Day 1 of Cycle 3 Participant 2	162 mcg/mL Standard Deviation NA Here, 'NA' signifies that standard deviation could not be calculated due to single evaluable participant.

SECONDARY outcome

Timeframe: Pre-dose, 0, 2, 6, 24, 72, 168, 240 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)

Terminal elimination half-life (t1/2) was the time measured for the serum concentration of a drug to decrease by half of its initial concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=4 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Terminal Elimination Half-Life (t1/2) of Amivantamab	201.3 Hours Standard Deviation 39.8

SECONDARY outcome

Timeframe: Pre-dose, 0, 24, 26, 30, 48, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 6, 24, 72 and 168 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days)

Accumulation ratio for AUC was calculated as AUC (0-168 h) for Cycle 2 Day 1 divided by AUC (0-168 h) for Cycle 1 Day 1. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=4 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Accumulation Ratio (AR) of AUC (0-168 h) of Amivantamab	2.85 Ratio Standard Deviation 0.46

SECONDARY outcome

Timeframe: From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 3.8 months)

Population: Immunogenicity analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable postbaseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants with appropriate samples had 1 or more samples obtained after their first amivantamab administration.

Number of participants with anti-amivantamab antibodies were reported. Serum samples were assessed for anti-drug antibodies.

Outcome measures

Outcome measures
Measure	Amivantamab Monotherapy (1050/1400 mg) n=15 Participants Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Number of Participants With Anti-Amivantamab Antibodies	0 Participants

Adverse Events

Amivantamab Monotherapy (1050/1400 mg)

Serious events: 4 serious events

Other events: 18 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Amivantamab Monotherapy (1050/1400 mg) n=18 participants at risk Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Gastrointestinal disorders Ascites	16.7% 3/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Haemorrhage	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.

Other adverse events

Other adverse events
Measure	Amivantamab Monotherapy (1050/1400 mg) n=18 participants at risk Participants with previously treated advanced hepatocellular carcinoma (HCC) received amivantamab 1050 milligrams (mg) for body weight less than (\<) 80 kilograms (kg) or 1400 mg for body weight greater than or equal to (\>=) 80 kg as an intravenous (IV) infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight \<80 kg/1050 mg for body weight \>=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until documented clinical or radiographic disease progression or until the participant discontinued study treatment due to withdrawal of consent, safety reasons, noncompliance with study drug administration or procedural requirements with treatment continuing for a maximum of up to 2.8 months. Participants were followed up for safety every 12 weeks after the last dose of study treatment or disease progression until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first.
Blood and lymphatic system disorders Anaemia	16.7% 3/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Leukocytosis	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Leukopenia	22.2% 4/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Neutropenia	22.2% 4/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 3/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Eye disorders Eye Pain	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Eye disorders Eye Swelling	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Eye disorders Vision Blurred	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal Pain	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal Pain Upper	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Duodenal Ulcer	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Gingival Bleeding	16.7% 3/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Nausea	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Stomatitis	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Vomiting	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
General disorders Asthenia	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
General disorders Oedema Peripheral	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
General disorders Pyrexia	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hepatic Function Abnormal	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	16.7% 3/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Infections and infestations Peritonitis	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Infections and infestations Pneumonia	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Infections and infestations Upper Respiratory Tract Infection	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Infusion Related Reaction	50.0% 9/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Alanine Aminotransferase Increased	27.8% 5/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Aspartate Aminotransferase Increased	27.8% 5/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Blood Alkaline Phosphatase Increased	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Blood Creatinine Increased	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Blood Glucose Increased	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Blood Urea Increased	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Gamma-Glutamyltransferase Increased	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Glomerular Filtration Rate Decreased	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Prothrombin Time Prolonged	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Urinary Occult Blood	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Weight Decreased	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Investigations Weight Increased	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Decreased Appetite	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperuricaemia	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	61.1% 11/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Pain	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Nervous system disorders Dizziness	16.7% 3/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Psychiatric disorders Insomnia	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Renal and urinary disorders Haematuria	22.2% 4/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Renal and urinary disorders Proteinuria	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	33.3% 6/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Onychomadesis	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	11.1% 2/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	61.1% 11/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Skin Exfoliation	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.
Vascular disorders Haematoma	5.6% 1/18 • All-cause mortality: From screening up to 4.8 months; Serious AEs and Other AEs: 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) All treated analysis set included all participants who received at least 1 dose of study treatment.

Additional Information

Global Medical Head Oncology

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER