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

NCT04945733 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: CR10902661186372GIC2001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Outcome Measures

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.

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

Secondary Outcomes (17)

• Disease Control Rate (DCR) Per RECIST Version 1.1

  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

  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

  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

  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

  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)

Study Arms (2)

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.

Drug: Amivantamab

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.

Drug: Amivantamab

Interventions

Amivantamab DRUG

Amivantamab will be administered intravenously.

Also known as: JNJ-61186372

Amivantamab: Esophageal Cancer (EC) Cohorts; Amivantamab: Gastric Cancer (GC) Cohorts

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (10)

National Cancer Center Hospital

Chūōku, 104 0045, Japan

Location

National Cancer Center Hospital East

Kashiwa, 277 8577, Japan

Location

Saitama Cancer center

Kitaadachi-gun, 362-0806, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Hokkaido University Hospital

Sapporo, 060-8648, Japan

Location

Tohoku University Hospital

Sendai, 980 8574, Japan

Location

Osaka University Hospital

Suita-shi, 565-0871, Japan

Location

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Tokyo, 113 8677, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135 8550, Japan

Location

Yokohama City University Medical Center

Yokohama, 232 0024, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Interventions

amivantamab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

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.

Results Point of Contact

• Title: Executive Medical Director
• Organization: Janssen Pharmaceutical K.K.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 30, 2021
• Study Start: August 30, 2021
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (10)