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TerminatedNCT04945733Updated Sep 19, 2024Results posted

A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer

A Phase 2 interventional study of Amivantamab in Stomach Neoplasms and Esophageal Neoplasms, sponsored by Janssen Pharmaceutical K.K.. Terminated at 10 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Janssen Pharmaceutical K.K. (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment

Why this study was terminated
Due to reconsideration of development strategy
Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Stomach Neoplasms
  • Esophageal Neoplasms
03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's enrollment of 62 is close to the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Janssen Pharmaceutical K.K. is the lead sponsor of 126 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.

Browse Janssen Pharmaceutical K.K. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must have histologically or cytologically confirmed gastric (including gastroesophageal junction [GEJ]) or esophageal cancer (EC) that is locally advanced, unresectable, or metastatic, and not eligible for curative treatment
  • Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. If only 1 measurable lesion exists, it may be used for the screening biopsy if the baseline tumor assessment scans are performed greater than or equal to (>=) 7 days after the biopsy
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

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

Exclusion Criteria:

  • Participant has an uncontrolled illness, including but not limited to the following: diabetes; ongoing or active bacterial infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week before enrollment]), symptomatic viral infection, or any other clinically significant infection; active bleeding diathesis and psychiatric illness/social situation that would limit compliance with study requirements
  • Participant has received prior epidermal growth factor receptor (EGFR) or tyrosine-protein kinase mesenchymal-epithelial transition (cMet)-directed therapies
  • Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives whichever is longer or had radiation therapy within 4 weeks before the first administration of study treatment. For agents with long half-lives, the maximum required time since last dose is 28 days. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less, (except for alopecia or post-radiation skin changes [any grade], Grade less than or equal to [\<=] 2 peripheral neuropathy, and Grade \<=2 hypothyroidism stable on hormone replacement)
  • Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to the first administration of study treatment is eligible), history of leptomeningeal disease or spinal cord compression that has not been treated definitively with surgery or radiation. If brain metastases are diagnosed on screening imaging, the participant may be rescreened for eligibility after definitive treatment
  • Participant has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. Esophageal cancer participants with history of completely resolved radiation pneumonitis (defined as radiographically stable for 3 months prior to enrollment without need of any treatment) may be enrolled
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Amivantamab: Gastric Cancer (GC) Cohorts

    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.

    Drug: Amivantamab

  • Experimental
    Amivantamab: Esophageal Cancer (EC) Cohorts

    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.

    Drug: Amivantamab

Interventions

  • DrugAmivantamab

    Amivantamab will be administered intravenously.

    Also known as: JNJ-61186372

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)

Secondary outcomes

  1. 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).

    Time frame: From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)

  2. 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.

    Time frame: From the date of first documented response up to date of first documented PD or death (up to 9 months)

  3. 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.

    Time frame: From first dose of study treatment until first documentation of CR or PR (up to 9 months)

  4. 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.

    Time frame: From day of first dose (Day 1) until PD or death (up to 9 months)

  5. 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.

    Time frame: 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)

  6. 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.

    Time frame: 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)

  7. 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.

    Time frame: 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)

  8. 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.

    Time frame: 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)

  9. 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.

    Time frame: 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)

  10. 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 \[1050/1400 mg\]).

    Time frame: 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)

  11. 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.

    Time frame: 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)

  12. 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.

    Time frame: 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)

  13. 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.

    Time frame: 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)

  14. 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.

    Time frame: 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)

  15. 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.

    Time frame: 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)

  16. 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.

    Time frame: 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)

  17. Number of Participants With Anti-Amivantamab Antibodies

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

    Time frame: From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)

07

Results

Posted Sep 19, 2024
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
MilestonePhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Started29303
Completed25243
Not completed460
Withdrew: Physician decision130
Withdrew: Withdrawal by subject330

Outcome measures

PrimaryObjective 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.

Time frame:
From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)
Reported as:
Number · Percentage of Participants
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Percentage of ParticipantsPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.14.3 (0.1 to 21.9)10.7 (2.3 to 28.2)0 (0.0 to 84.2)
SecondaryDisease 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).

Time frame:
From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)
Reported as:
Number · Percentage of Participants
Disease Control Rate (DCR) Per RECIST Version 1.1
Percentage of ParticipantsPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Disease Control Rate (DCR) Per RECIST Version 1.126.1 (10.2 to 48.4)67.9 (47.6 to 84.1)100 (15.8 to 100)
SecondaryDuration 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.

Time frame:
From the date of first documented response up to date of first documented PD or death (up to 9 months)
Reported as:
Median · Months
Duration of Response (DOR) as Per RECIST Version 1.1
MonthsPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Duration of Response (DOR) as Per RECIST Version 1.1NA (NA to NA)2.86 (2.79 to NA)—
SecondaryTime 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.

Time frame:
From first dose of study treatment until first documentation of CR or PR (up to 9 months)
Reported as:
Median · Months
Time to Response (TTR) as Per RECIST Version 1.1
MonthsPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Time to Response (TTR) as Per RECIST Version 1.11.45 (NA to NA)1.41 (1.41 to NA)—
SecondaryProgression 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.

Time frame:
From day of first dose (Day 1) until PD or death (up to 9 months)
Reported as:
Median · Months
Progression Free Survival (PFS) as Per RECIST Version 1.1
MonthsPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Progression Free Survival (PFS) as Per RECIST Version 1.11.45 (1.41 to 1.48)4.11 (2.10 to 4.17)2.99 (1.41 to NA)
SecondaryNumber 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.

Time frame:
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)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
ParticipantsPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Grade 1431
Grade 214171
Grade 3891
Grade 4000
Grade 5310
SecondaryMaximum 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.

Time frame:
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)
Reported as:
Mean · Micrograms per milliliter (mcg/mL)
Maximum Observed Serum Concentration (Cmax) for Amivantamab
Micrograms per milliliter (mcg/mL)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)
Cycle 1 Day 1356 ± 91.6370 ± 78.2—363 ± 84.0
Cycle 2 Day 1820 ± 221866 ± 196—845 ± 202
SecondaryTime 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.

Time frame:
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)
Reported as:
Median · Hours (h)
Time to Reach Maximum Observed Serum Concentration (Tmax) for Amivantamab
Hours (h)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)
Cycle 1 Day 128.42 (27.02 to 31.00)29.65 (28.80 to 31.62)—29.23 (27.02 to 31.62)
Cycle 2 Day 14.23 (2.42 to 24.63)2.53 (2.27 to 4.53)—3.46 (2.27 to 24.63)
SecondaryArea 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.

Time frame:
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)
Reported as:
Mean · micrograms*hours/milliliter (mcg*hr/mL)
Area Under the Curve From Time (0) to Time (168h) (AUC [0-168h]) for Amivantamab
micrograms*hours/milliliter (mcg*hr/mL)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)
Area Under the Curve From Time (0) to Time (168h) (AUC [0-168h]) for Amivantamab30990 ± 834631548 ± 7854—31269 ± 7930
SecondaryArea 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.

Time frame:
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)
Reported as:
Mean · micrograms*hours/milliliter (mcg*hr/mL)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amivantamab
micrograms*hours/milliliter (mcg*hr/mL)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amivantamab137806 ± 19006162171 ± 45328—154049 ± 39369
SecondaryPhase 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 \[1050/1400 mg\]).

Time frame:
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)
Reported as:
Mean · Micrograms per milliliter (mcg/mL)
Phase 2a Gastric Cancer and Esophageal Cancer Cohorts: Serum Trough Concentrations (Ctrough) of Amivantamab
Micrograms per milliliter (mcg/mL)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)
Pre-dose Cycle 1 Day 8119 ± 34.9136 ± 45.1128 ± 40.5
Pre-dose Cycle 1 Day 15214 ± 73.7222 ± 74.6218 ± 73.5
Pre-dose Cycle 2 Day 1308 ± 99.5342 ± 77.4327 ± 88.5
Pre-dose Cycle 2 Day 15231 ± 85.6259 ± 80.7250 ± 82.0
Pre-dose Cycle 3 Day 1166 ± 86.6234 ± 58.5217 ± 70.3
Pre-dose Cycle 3 Day 15154 ± 83.3210 ± 87.1198 ± 87.1
Pre-dose Cycle 4 Day 1105 ± 73.2236 ± 82.8210 ± 95.4
Pre-dose Cycle 4 Day 15139.0 ± NA203 ± 54.1198 ± 54.8
Pre-dose Cycle 6 Day 1122.3 ± NA190 ± 35.7173 ± 44.7
Pre-dose Cycle 8 Day 1111.4 ± NA100.0 ± NANA ± NA
SecondaryPhase 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.

Time frame:
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)
Reported as:
Mean · Micrograms per milliliter (mcg/mL)
Phase 2a Esophageal Cancer Higher Dose Cohort: Serum Trough Concentrations (Ctrough) of Amivantamab
Micrograms per milliliter (mcg/mL)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Pre-dose Cycle 1 Day 15: Participant 1333 ± NA
Pre-dose Cycle 1 Day 15: Participant 2337 ± NA
Pre-dose Cycle 2 Day 1: Participant 1657 ± NA
Pre-dose Cycle 2 Day 1: Participant 2779 ± NA
Pre-dose Cycle 2 Day 15: Participant 1590 ± NA
Pre-dose Cycle 2 Day 15: Participant 2604 ± NA
Pre-dose Cycle 3 Day 1: Participant 1433 ± NA
Pre-dose Cycle 3 Day 1: Participant 2600 ± NA
Pre-dose Cycle 3 Day 15: Participant 1460 ± NA
Pre-dose Cycle 6 Day 1: Participant 1295 ± NA
Pre-dose Cycle 8 Day 1: Participant 1314 ± NA
SecondaryPhase 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.

Time frame:
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)
Reported as:
Mean · Hours
Phase 2a Gastric Cancer Cohort: Terminal Elimination Half-Life (t1/2) for Amivantamab
HoursPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)
Participant 1226.0 ± NA
Participant 2264.5 ± NA
SecondaryPhase 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.

Time frame:
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)
Reported as:
Mean · Hours
Phase 2a Esophageal Cancer and Overall Combined Cohorts: Terminal Elimination Half-Life (t1/2) for Amivantamab
HoursPhase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)
Phase 2a Esophageal Cancer and Overall Combined Cohorts: Terminal Elimination Half-Life (t1/2) for Amivantamab254.7 ± 43.0—252.6 ± 38.7
SecondaryApparent 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.

Time frame:
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)
Reported as:
Mean · Liters/hour (L/h)
Apparent Clearance at Steady State (CLss) of Amivantamab
Liters/hour (L/h)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)
Apparent Clearance at Steady State (CLss) of Amivantamab0.00775 ± 0.001220.00695 ± 0.00200—0.00722 ± 0.00176
SecondaryApparent 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.

Time frame:
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)
Reported as:
Mean · Liters
Apparent Volume of Distribution at Steady State (Vss) of Amivantamab
LitersPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)
Apparent Volume of Distribution at Steady State (Vss) of Amivantamab3.59 ± NA2.61 ± 1.04—2.75 ± 1.02
SecondaryAccumulation 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.

Time frame:
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)
Reported as:
Mean · Ratio
Accumulation Ratio (AR) of AUCtau for Amivantamab
RatioPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Overall: Phase 2a GC and EC Combined Cohorts: Amivantamab (1050/1400 mg)
Accumulation Ratio (AR) of AUCtau for Amivantamab4.32 ± 0.515.12 ± 0.72—4.85 ± 0.74
SecondaryNumber of Participants With Anti-Amivantamab Antibodies

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

Time frame:
From start of the treatment (Day 1) up to 30 days after the last dose of study drug (up to 9 months)
Reported as:
Count of participants · Participants
Number of Participants With Anti-Amivantamab Antibodies
ParticipantsPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Number of Participants With Anti-Amivantamab Antibodies000

Adverse events

Collected over 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). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)5/29 (17.2%)9/29 (31%)28/29 (96.6%)
Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)2/30 (6.7%)7/30 (23.3%)30/30 (100%)
Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)0/3 (0%)0/3 (0%)3/3 (100%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Disease ProgressionGeneral disorders2/290/300/3
EmbolismVascular disorders2/290/300/3
Gastrointestinal PerforationGastrointestinal disorders1/290/300/3
Bile Duct StenosisHepatobiliary disorders1/290/300/3
Retroperitoneal AbscessInfections and infestations1/290/300/3
Kidney RuptureInjury, poisoning and procedural complications1/290/300/3
Decreased AppetiteMetabolism and nutrition disorders1/290/300/3
PneumothoraxRespiratory, thoracic and mediastinal disorders1/290/300/3
BradycardiaCardiac disorders0/291/300/3
Adrenal InsufficiencyEndocrine disorders0/291/300/3
Most frequent other events
Showing 10 of 37
Most frequent other events
EventPhase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)
Covid-19Infections and infestations1/294/303/3
HypoalbuminaemiaMetabolism and nutrition disorders12/2910/302/3
HaematuriaRenal and urinary disorders0/290/302/3
Dermatitis AcneiformSkin and subcutaneous tissue disorders10/2917/302/3
Infusion Related ReactionInjury, poisoning and procedural complications12/2913/301/3
RashSkin and subcutaneous tissue disorders11/299/300/3
KeratitisEye disorders0/290/301/3
NauseaGastrointestinal disorders7/295/301/3
MalaiseGeneral disorders5/295/301/3
Oedema PeripheralGeneral disorders7/295/301/3

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Total
<=18 years0000
Between 18 and 65 years1318233
>=65 years1612129
Age, Continuous
Age, Continuous(years)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Total
Mean64 ± 11.9762.7 ± 10.3560 ± 963.2 ± 10.97
Sex: Female, Male
Sex: Female, Male(Participants)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Total
Female56011
Male2424351
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Total
Hispanic or Latino0000
Not Hispanic or Latino2930362
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Total
American Indian or Alaska Native0000
Asian2930362
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White0000
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(Participants)Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg)Phase 2a Esophageal Cancer Higher Dose Cohort: Amivantamab (1750/2100 mg)Total
JAPAN2930362
08

Study locations

10 sites
  • National Cancer Center Hospital
    Chūōku, 104 0045, Japan
  • National Cancer Center Hospital East
    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
09

References and documents

Study documents

  • Study protocol · Aug 16, 2022
  • Statistical analysis plan · Aug 11, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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

Data sharing details ↗ · www.janssen.com

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04945733
Lead sponsor
Janssen Pharmaceutical K.K.
Responsible party
Sponsor
First posted
Jun 30, 2021
Start date
Aug 30, 2021
Primary completion
Jul 3, 2023
Completion
Jul 3, 2023
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Study contacts

Janssen Pharmaceutical K.K., Japan Clinical Trial
study director · Janssen Pharmaceutical K.K.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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