| Primary | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From start of treatment on Day 1 up to 3.8 months | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Duration of Response (DOR) as Per RECIST Version 1.1 | 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. | 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. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | | | | | From the date of first documented response up to date of first documented PD or death (up to 3.8 months) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Disease Control Rate (DCR) as Per RECIST Version 1.1 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From start of treatment on Day 1 up to 3.8 months | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Progression Free Survival (PFS) as Per RECIST Version 1.1 | 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. | 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. | Posted | | Median | 95% Confidence Interval | Months | | From start of the treatment (Day 1) until disease progression or death (up to 3.8 months) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of first dose of study drug until the date of death due to any cause. | 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. | Posted | | Median | 95% Confidence Interval | Months | | From start of the treatment (Day 1) until death due to any cause (up to 3.8 months) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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 | 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. | All treated analysis set included all participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | 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. | All treated analysis set included all participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs Values | 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. | All treated analysis set included all participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Amivantamab | 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. | 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. | Posted | | Mean | Standard Deviation | Micrograms per milliliter (mcg/mL) | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) of Amivantamab | 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. | 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. | Posted | | Median | Full Range | Hours | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Area Under the Serum Concentration Time Curve From Time Zero to Time 168 Hours (h) (AUC [0-168h]) of Amivantamab | 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. | 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. | Posted | | Mean | Standard Deviation | micrograms*hours/milliliter (mcg*hr/mL) | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Area Under the Serum Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Amivantamab | 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. | 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. | Posted | | Mean | Standard Deviation | mcg*hr/mL | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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 | 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. | 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. | Posted | | Mean | Standard Deviation | mcg/mL | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Serum Trough Concentrations (Ctrough) of Amivantamab: on Day 1 of Cycle 3 | 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. | 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. | Posted | | Mean | Standard Deviation | mcg/mL | | Pre-dose at 0 hour on Day 1 of Cycle 3 (each cycle was of 28 days) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Terminal Elimination Half-Life (t1/2) of Amivantamab | 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. | 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. | Posted | | Mean | Standard Deviation | Hours | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Accumulation Ratio (AR) of AUC (0-168 h) of Amivantamab | 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. | 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. | Posted | | Mean | Standard Deviation | Ratio | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants With Anti-Amivantamab Antibodies | Number of participants with anti-amivantamab antibodies were reported. Serum samples were assessed for anti-drug antibodies. | 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. | Posted | | Count of Participants | | Participants | | From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 3.8 months) | | | | ID | Title | Description |
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| OG000 | 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. |
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