EGFR-targeted Therapy for Gastric Cancer

November 29, 2022 updated by: Hark Kyun Kim, National Cancer Center, Korea

Anti-EGFR Antibody (GC-1118) in Combination With Weekly Paclitaxel as a Second-line Therapy for Gastric and Gastroesophageal Junction Adenocarcinomas With Amplifications

Based on targeted NGS panel results, metastatic gastric cancer patients with gene amplifications will receive either anti-EGFR antibody (GC-1118) in combination with weekly paclitaxel as a second-line therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will receive each treatment if the gastric cancer tissue sample reveals either EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Study Type

Interventional

Enrollment (Anticipated)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hark K Kim, M.D.,Ph.D
  • Phone Number: +82-31-920-2238
  • Email: hkim@ncc.re.kr

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key inclusion criteria

  1. Histologically-proven gastric and gastroesophageal junction adenocarcinoma
  2. Refractory to first-line chemotherapy for metastatic disease
  3. Presence of at least 1 measurable lesion according to RECIST version 1.1
  4. EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Key exclusion criteria

1.Prior exposure to taxane or EGFR-targeted therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: anti-EGFR
Participants will receive GC-1118 in combination with weekly paclitaxel.
Drug: Anti-EGFR antibody in combination with weekly paclitaxel
Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy
Other Names:
  • GC-1118 in combination with weekly paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: Response rate will be assessed at 8 weeks.
Response rate will be assessed using CT/MRI according to RECIST v1.1.
Response rate will be assessed at 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed up to 1 year.
Time from date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed.
From date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed up to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Collaborators

Korean Cancer Study Group

Investigators

  • Principal Investigator: Hark K Kim, M.D.,Ph.D, National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (ACTUAL)

September 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31973

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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