Description:
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).
Title
- Brief Title: A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer
- Official Title: A Phase 2, Open-label Study of Amivantamab in Subjects With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer
Clinical Trial IDs
- ORG STUDY ID:
CR109026
- SECONDARY ID:
61186372GIC2001
- NCT ID:
NCT04945733
Conditions
- Stomach Neoplasms
- Esophageal Neoplasms
Interventions
Drug | Synonyms | Arms |
---|
Amivantamab | JNJ-61186372 | Amivantamab: Esophageal Cancer (EC) Cohorts |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
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). Phase 2b GC expansion cohorts will be initiated if activity is observed within Phase 2a cohorts. | |
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). Phase 2b EC expansion cohorts will be initiated if activity is observed within Phase 2a cohorts. | |
Eligibility Criteria
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:
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | ORR is defined as the percentage of participants who achieve either complete response (CR) or partial response (PR), determined by investigator assessment using response evaluation criteria in solid tumors (RECIST) version 1.1. |
Secondary Outcome Measures
Measure: | Disease Control Rate (DCR) |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | DCR is defined as the percentage of participants achieving complete or partial response or stable disease for at least 6 weeks as defined by RECIST Version1.1. |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first. |
Measure: | Progression-free Survival (PFS) |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | PFS is defined as the time from first dose 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. |
Measure: | Phase 2b: Overall Survival (OS) |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | OS is defined as the time from the date of first dose until the date of death due to any cause. |
Measure: | Number of Participants with Adverse Events (AEs) |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Measure: | Maximum Serum Concentration (Cmax) of Amivantamab |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | Cmax is defined as maximum concentration of amivantamab. |
Measure: | Time to Reach Maximum Concentration (Tmax) of Amivantamab |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | Tmax is defined as time to reach maximum serum concentration of amivantamab. |
Measure: | Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of Amivantamab |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2. |
Measure: | Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval. |
Measure: | Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | Ctrough is defined as the serum concentration of amivantamab immediately prior to the next drug administration. |
Measure: | Accumulation Ratio (RA) of Amivantamab |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | RA is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose. |
Measure: | Number of Participants with Anti-Amivantamab Antibodies |
Time Frame: | Up to 1 year and 10 months |
Safety Issue: | |
Description: | Serum samples will be collected to detect the anti-drug antibodies to amivantamab. The detection and characterization of antibodies to amivantamab will be performed using a validated immunoassay method. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Janssen Pharmaceutical K.K. |
Last Updated
August 17, 2021