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| ID | Type | Description | Link |
|---|---|---|---|
| 61186372GIC2001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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Due to reconsideration of development strategy
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The purpose of this study is to investigate the activity of amivantamab in gastric cancer (GC) and esophageal cancer (EC) participants (Phase 2a), and to characterize the preliminary antitumor activity of amivantamab in selected GC and EC population (Phase 2b).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amivantamab: Gastric Cancer (GC) Cohorts | Experimental | Participants in Phase 2a GC cohorts will receive intravenous (IV) infusion of weight-based dose of amivantamab in 28-day cycles. Participants with body weight less than (<) 80 kilograms (kg) will receive IV infusion of amivantamab 1,050 milligrams (mg) and participants with body weight greater than or equal to (>=) 80 kg will receive IV infusion of amivantamab 1,400 mg once weekly in Cycle 1 and then every 2 weeks in subsequent cycles (on Days 1 and 15 of each cycle), followed by additional dosing based on body weight if recommended by clinical trial management team (CTMT) (amivantamab 1750 mg for body weight <80 kg and 2100 mg for body weight >=80 kg as IV infusion) every 2 weeks on Days 1 and 15 of 28 day cycle. Phase 2b GC expansion cohorts will be initiated if activity is observed within Phase 2a cohorts. |
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| Amivantamab: Esophageal Cancer (EC) Cohorts | Experimental | Participants in Phase 2a EC cohorts will receive IV infusion of weight-based dose of amivantamab in 28-day cycles. Participants with body weight <80 kg will receive IV infusion of amivantamab 1,050 mg and participants with body weight >=80 kg will receive IV infusion of amivantamab 1,400 mg once weekly in Cycle 1 and then every 2 weeks in subsequent cycles (on Days 1 and 15 of each cycle) followed by additional dosing based on body weight if recommended by CTMT (amivantamab 1750 mg for body weight <80 kg and 2100 mg for body weight >=80 kg as IV infusion) every 2 weeks on Days 1 and 15 of 28 day cycle. Phase 2b EC expansion cohorts will be initiated if activity is observed within Phase 2a cohorts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amivantamab | Drug | Amivantamab will be administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 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 target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<)10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. | From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) Per RECIST Version 1.1 | DCR was defined as the percentage of participants achieving CR or PR or stable disease (SD) for at least 6 weeks as defined by RECIST version 1.1. As per RECIST version 1.1 CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR was defined as >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and no appearance of new lesion(s). |
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Inclusion Criteria:
Gastric or GEJ Cancer Only - Must be refractory or ineligible to at least 2 prior lines of standard of care systemic therapy. Prior therapies must include fluoropyrimidine- and platinum-based chemotherapy. Participants with known human epidermal growth factor receptor (HER) 2 expression must have had HER2 targeting therapy as part of the prior therapy
Esophageal Cancer Only
- Must be refractory or intolerant to at least 1 prior line of systemic therapy. Prior therapies must include fluoropyrimidine-, and platinum-based chemotherapy (including chemoradiation therapy given as stage intravenous [IV] setting)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital | Chūōku | 104 0045 | Japan | |||
| National Cancer Center Hospital East |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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The study was planned to be conducted in 2 cohorts: Phase 2a cohorts (including Phase 2a extension cohort) and Phase 2b expansion cohort in participants with previously treated advanced or metastatic gastric or esophageal cancer. However, due to study termination, no participants were enrolled in Phase 2a extension cohorts and Phase 2b cohorts. Hence the results were only presented for Phase 2a cohorts.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) 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 disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2022 | Jul 3, 2024 |
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| From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months) |
| Duration of Response (DOR) as Per RECIST Version 1.1 | DOR was defined as time between date of first documented response (CR/PR) and date of first documented progression or death, whichever occurred first. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures <10 mm. PR was defined as >=30% decrease in sum of measures (tumor lesions-longest diameter and nodes-short axis) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. There was no participant who had event (CR/PR) in Phase 2a EC higher dose cohort, hence data could not be collected and analyzed for this cohort. | From the date of first documented response up to date of first documented PD or death (up to 9 months) |
| Time to Response (TTR) as Per RECIST Version 1.1 | TTR was defined as time from date of first amivantamab administration to date of achieving objective response (CR/PR) as assessed by investigator per RECIST v1.1 among participants who achieved objective response. Per RECIST v1.1, CR: disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. There was no participant who had event (CR/PR) in Phase 2a EC higher dose cohort, hence data could not be collected and analyzed for this cohort. | From first dose of study treatment until first documentation of CR or PR (up to 9 months) |
| 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 in the absence of progression), whichever comes first, based on investigator assessment using RECIST Version 1.1. | From day of first dose (Day 1) until PD or death (up to 9 months) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | 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 v5.0. 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 are reported in this outcome measure. | From start of the treatment (Day 1) up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (up to 9 months) |
| Maximum Observed Serum Concentration (Cmax) for 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. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for Cmax was not collected and analyzed for Phase 2a EC higher dose cohort. | Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
| Time to Reach Maximum Observed Serum Concentration (Tmax) for 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. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for Tmax was not collected and analyzed for Phase 2a EC higher dose cohort. | Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
| Area Under the Curve From Time (0) to Time (168h) (AUC [0-168h]) for 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. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for AUC (0-168h) was not collected and analyzed for Phase 2a EC higher dose cohort. | Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1 (each cycle was of 28 days) |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amivantamab | Area under the serum concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 336 hours was reported. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for AUCtau was not collected and analyzed for Phase 2a EC higher dose cohort. | Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
| Phase 2a Gastric Cancer and Esophageal Cancer Cohorts: Serum Trough Concentrations (Ctrough) of Amivantamab | Ctrough of amivantamab in GC and EC cohorts 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. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). | Pre-dose at 0 hour: Days 8 and 15 of Cycle 1; Days 1 and 15 of Cycles 2, 3 and 4; Day 1 of Cycles 6 and 8 (each cycle was of 28 days) |
| Phase 2a Esophageal Cancer Higher Dose Cohort: Serum Trough Concentrations (Ctrough) of Amivantamab | Ctrough of amivantamab in phase 2a EC higher dose cohort was reported. Ctrough was defined as pre-dose serum drug concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. | Pre-dose at 0 hour: Day 15 of Cycle 1; Days 1 and 15 of Cycles 2 and 3; Day 1 of Cycles 6 and 8 (each cycle was of 28 days) |
| Phase 2a Gastric Cancer Cohort: Terminal Elimination Half-Life (t1/2) for 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. | Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
| Phase 2a Esophageal Cancer and Overall Combined Cohorts: Terminal Elimination Half-Life (t1/2) for 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. Data for this outcome measure was planned to be collected and analyzed for EC cohort and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for t1/2 was not collected and analyzed for Phase 2a EC higher dose cohort. | Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
| Apparent Clearance at Steady State (CLss) of Amivantamab | Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for CLss was not collected and analyzed for Phase 2a EC higher dose cohort. | Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
| Apparent Volume of Distribution at Steady State (Vss) of Amivantamab | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for Vss was not collected and analyzed for Phase 2a EC higher dose cohort. | Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
| Accumulation Ratio (AR) of AUCtau for Amivantamab | Accumulation ratio for AUC was calculated as AUC (0-336h) for Cycle 2 Day 1 divided by AUC (0-168h) for Cycle 1 Day 1. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for AR of AUCtau was not collected and analyzed for Phase 2a EC higher dose cohort. | Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
| Number of Participants With Anti-Amivantamab Antibodies | Number of participants with anti-amivantamab antibodies were reported. Serum samples were assessed for anti-drug antibodies. | From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months) |
| Kashiwa |
| 277 8577 |
| Japan |
| Saitama Cancer center | Kitaadachi-gun | 362-0806 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Hokkaido University Hospital | Sapporo | 060-8648 | Japan |
| Tohoku University Hospital | Sendai | 980 8574 | Japan |
| Osaka University Hospital | Suita-shi | 565-0871 | Japan |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Tokyo | 113 8677 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135 8550 | Japan |
| Yokohama City University Medical Center | Yokohama | 232 0024 | Japan |
| FG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| FG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) 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 disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| BG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| BG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| BG003 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 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 target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<)10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. | Response evaluable analysis set included all participants who received at least 1 dose of study treatment, met all eligibility criteria for the study and had a baseline and at least 1 post-baseline efficacy disease assessments, or had disease progression/death due to disease progression prior to the first post-baseline disease assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months) |
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| Secondary | Disease Control Rate (DCR) Per RECIST Version 1.1 | DCR was defined as the percentage of participants achieving CR or PR or stable disease (SD) for at least 6 weeks as defined by RECIST version 1.1. As per RECIST version 1.1 CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR was defined as >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and no appearance of new lesion(s). | Response evaluable analysis set included all participants who received at least 1 dose of study treatment, met all eligibility criteria for the study and had a baseline and at least 1 post-baseline efficacy disease assessments, or had disease progression/death due to disease progression prior to the first post-baseline disease assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months) |
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| Secondary | Duration of Response (DOR) as Per RECIST Version 1.1 | DOR was defined as time between date of first documented response (CR/PR) and date of first documented progression or death, whichever occurred first. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures <10 mm. PR was defined as >=30% decrease in sum of measures (tumor lesions-longest diameter and nodes-short axis) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. There was no participant who had event (CR/PR) in Phase 2a EC higher dose cohort, hence data could not be collected and analyzed for this cohort. | Response evaluable analysis set included all participants who received at least 1 dose of study treatment, met all eligibility criteria for study and had a baseline and at least 1 post-baseline efficacy disease assessments, or had disease progression/death due to disease progression prior to first post-baseline disease assessment. Here 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From the date of first documented response up to date of first documented PD or death (up to 9 months) |
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| Secondary | Time to Response (TTR) as Per RECIST Version 1.1 | TTR was defined as time from date of first amivantamab administration to date of achieving objective response (CR/PR) as assessed by investigator per RECIST v1.1 among participants who achieved objective response. Per RECIST v1.1, CR: disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. For non-target lesions, PD: unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. There was no participant who had event (CR/PR) in Phase 2a EC higher dose cohort, hence data could not be collected and analyzed for this cohort. | Response evaluable analysis set included all participants who received at least 1 dose of study treatment, met all eligibility criteria for study and had a baseline and at least 1 post-baseline efficacy disease assessments, or had disease progression/death due to disease progression prior to first post-baseline disease assessment. Here 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From first dose of study treatment until first documentation of CR or PR (up to 9 months) |
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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 in the absence of progression), whichever comes first, based on investigator assessment using RECIST Version 1.1. | All treated analysis set included all participants who took at least 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | From day of first dose (Day 1) until PD or death (up to 9 months) |
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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 v5.0. 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 are reported in this outcome measure. | The safety analysis set included all participants who took 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 or start of new anticancer therapy, whichever occurred first (up to 9 months) |
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| Secondary | Maximum Observed Serum Concentration (Cmax) for 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. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for Cmax was not collected and analyzed for Phase 2a EC higher dose cohort. | The pharmacokinetics (PK) analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure and 'n' (number analyzed) = refers to participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Micrograms per milliliter (mcg/mL) | Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
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| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) for 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. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for Tmax was not collected and analyzed for Phase 2a EC higher dose cohort. | The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure and 'n' (number analyzed) = refers to participants evaluable at specified time points. | Posted | Median | Full Range | Hours (h) | Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
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| Secondary | Area Under the Curve From Time (0) to Time (168h) (AUC [0-168h]) for 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. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for AUC (0-168h) was not collected and analyzed for Phase 2a EC higher dose cohort. | The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | micrograms*hours/milliliter (mcg*hr/mL) | Pre-dose, 0, 24, 26, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1 (each cycle was of 28 days) |
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| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amivantamab | Area under the serum concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 336 hours was reported. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for AUCtau was not collected and analyzed for Phase 2a EC higher dose cohort. | The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | micrograms*hours/milliliter (mcg*hr/mL) | Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
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| Secondary | Phase 2a Gastric Cancer and Esophageal Cancer Cohorts: Serum Trough Concentrations (Ctrough) of Amivantamab | Ctrough of amivantamab in GC and EC cohorts 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. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). | The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure and 'n' (number analyzed) = refers to participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Micrograms per milliliter (mcg/mL) | Pre-dose at 0 hour: Days 8 and 15 of Cycle 1; Days 1 and 15 of Cycles 2, 3 and 4; Day 1 of Cycles 6 and 8 (each cycle was of 28 days) |
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| Secondary | Phase 2a Esophageal Cancer Higher Dose Cohort: Serum Trough Concentrations (Ctrough) of Amivantamab | Ctrough of amivantamab in phase 2a EC higher dose cohort was reported. Ctrough was defined as pre-dose serum drug concentration. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. | The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) = the participants evaluable for this outcome measure and 'n' (number analyzed) = participants evaluable at specified time points. As planned participant wise data was collected and analyzed when "n" was less than (<) 3. | Posted | Mean | Standard Deviation | Micrograms per milliliter (mcg/mL) | Pre-dose at 0 hour: Day 15 of Cycle 1; Days 1 and 15 of Cycles 2 and 3; Day 1 of Cycles 6 and 8 (each cycle was of 28 days) |
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| Secondary | Phase 2a Gastric Cancer Cohort: Terminal Elimination Half-Life (t1/2) for 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. | The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) = the participants evaluable for this outcome measure and 'n' (number analyzed) = participants evaluable at specified row. As planned participant wise data was collected and analyzed when "n" was <3. | Posted | Mean | Standard Deviation | Hours | Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
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| Secondary | Phase 2a Esophageal Cancer and Overall Combined Cohorts: Terminal Elimination Half-Life (t1/2) for 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. Data for this outcome measure was planned to be collected and analyzed for EC cohort and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for t1/2 was not collected and analyzed for Phase 2a EC higher dose cohort. | The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline 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, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
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| Secondary | Apparent Clearance at Steady State (CLss) of Amivantamab | Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for CLss was not collected and analyzed for Phase 2a EC higher dose cohort. | The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Liters/hour (L/h) | Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
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| Secondary | Apparent Volume of Distribution at Steady State (Vss) of Amivantamab | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for Vss was not collected and analyzed for Phase 2a EC higher dose cohort. | The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. Here 'N' (overall number of participants analyzed) refers to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Liters | Pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
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| Secondary | Accumulation Ratio (AR) of AUCtau for Amivantamab | Accumulation ratio for AUC was calculated as AUC (0-336h) for Cycle 2 Day 1 divided by AUC (0-168h) for Cycle 1 Day 1. The concentrations of amivantamab were measured using a validated, specific, and sensitive ELISA method. Data for this outcome measure was planned to be collected and analyzed for each cancer type (GC and EC) and overall participants (GC and EC combined cohorts: Amivantamab [1050/1400 mg]). As planned, data for AR of AUCtau was not collected and analyzed for Phase 2a EC higher dose cohort. | The PK analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline 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, 48, 72, 96 and 168 hours post-dose on Day 1 of Cycle 1; pre-dose, 0, 2, 24, 48, 72, 168 and 336 hours post-dose on Day 1 of Cycle 2 (each cycle was of 28 days) |
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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. | The immunogenicity analysis set included all participants who received at least 1 dose of study treatment and had at least 1 evaluable post-baseline measurement. | 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 9 months) |
|
All-cause mortality: From screening up to 30 days after last dose of study drug (up to 10 months); Serious AEs and Other AEs: From start of the treatment (Day 1) up to 30 days after last dose of study drug (up to 9 months)
The safety analysis set included all participants who took at least 1 dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic gastric/gastroesophageal junction cancer (GC) exhibiting varying degrees of epidermal growth factor receptor (EGFR), tyrosine-protein kinase mesenchymal-epithelial transition (MET), or both as determined by immunohistochemistry (IHC) 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 disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. | 5 | 29 | 9 | 29 | 28 | 29 |
| EG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. | 2 | 30 | 7 | 30 | 30 | 30 |
| EG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. | 0 | 3 | 0 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Gastrointestinal Perforation | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Oesophageal Stenosis | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Retroperitoneal Abscess | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Kidney Rupture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Radiation Pneumonitis | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Eastern Cooperative Oncology Group Performance Status Worsened | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Tumour Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Tracheal Stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Liver Disorder | Hepatobiliary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Eastern Cooperative Oncology Group Performance Status Worsened | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Skin Fissures | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
|
The study was planned to be conducted in 2 cohorts: Phase 2a cohorts (including Phase 2a extension cohort) and Phase 2b expansion cohort. However, due to study termination, no participants were enrolled in Phase 2a extension and Phase 2b cohorts. Hence results were only presented for Phase 2a cohorts. Phase 2b specific outcome measure (overall survival) were not included in the results.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Janssen Pharmaceutical K.K. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2023 | Jul 3, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718215 | amivantamab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
|
|
| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
|
|
| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
|
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| OG001 |
| Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) |
Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG003 | Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG003 | Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG003 | Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG003 | Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| OG001 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG003 | Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG003 | Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| OG001 | Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG003 | Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg) | Participants with previously treated advanced or metastatic GC and EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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| Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg) |
Participants with previously treated advanced or metastatic esophageal cancer (EC) exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1050 mg for body weight <80 kg or 1400 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (700 mg for body weight <80 kg or 1050 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
| OG002 | Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg) | Participants with previously treated advanced or metastatic EC exhibiting varying degrees of EGFR, MET, or both as determined by IHC received amivantamab 1750 mg for body weight <80 kg or 2100 mg for body weight >=80 kg as an IV infusion in each 28-day cycles. During Cycle 1, amivantamab was administered once weekly on Days 1, 8, 15 and 22 with the first dose split over Day 1 (350 mg) and Day 2 (1400 mg for body weight <80 kg or 1750 mg for body weight >=80 kg). From Cycle 2 onwards, amivantamab was administered on Days 1 and 15 until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death whichever comes first. Participants were followed up for safety up to 30 days after the last dose. |
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