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

Stomach Neoplasms Clinical Trial

Official title:

A Phase 2, Open-label Study of Amivantamab in Subjects With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04945733
• Other study ID #: CR109026
• Secondary ID: 61186372GIC2001
• Status: Terminated
• Phase: Phase 2
• Start date: August 30, 2021
• Est. completion date: July 3, 2023

Study information

• Verified date: March 2024
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: July 3, 2023
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• Amivantamab
Amivantamab will be administered intravenously.

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo-Ku
Japan	National Cancer Center Hospital East	Kashiwa
Japan	Saitama Cancer center	Kitaadachi-gun
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Hokkaido University Hospital	Sapporo-shi
Japan	Tohoku University Hospital	Sendai
Japan	Osaka University Hospital	Suita-shi
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Japan	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital	Tokyo
Japan	Yokohama City University Medical Center	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	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.	Up to 1 year and 10 months
Secondary	Disease Control Rate (DCR)	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.	Up to 1 year and 10 months
Secondary	Duration of Response (DOR)	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.	Up to 1 year and 10 months
Secondary	Time to Response (TTR)	TTR is defined as the time from the date of first amivantamab administration to the date of achieving objective response (CR or PR) by investigator assessment using RECIST Version 1.1 among participants who achieve objective response.	Up to 1 year and 10 months
Secondary	Progression-free Survival (PFS)	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.	Up to 1 year and 10 months
Secondary	Phase 2b: Overall Survival (OS)	OS is defined as the time from the date of first dose until the date of death due to any cause.	Up to 1 year and 10 months
Secondary	Number of Participants with Adverse Events (AEs)	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.	Up to 1 year and 10 months
Secondary	Maximum Serum Concentration (Cmax) of Amivantamab	Cmax is defined as maximum concentration of amivantamab.	Up to 1 year and 10 months
Secondary	Time to Reach Maximum Concentration (Tmax) of Amivantamab	Tmax is defined as time to reach maximum serum concentration of amivantamab.	Up to 1 year and 10 months
Secondary	Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of Amivantamab	AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.	Up to 1 year and 10 months
Secondary	Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau)	AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.	Up to 1 year and 10 months
Secondary	Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough)	Ctrough is defined as the serum concentration of amivantamab immediately prior to the next drug administration.	Up to 1 year and 10 months
Secondary	Accumulation Ratio (RA) of Amivantamab	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.	Up to 1 year and 10 months
Secondary	Number of Participants with Anti-Amivantamab Antibodies	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.	Up to 1 year and 10 months