EGFR-targeted Therapy for Gastric Cancer

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

Sponsors

Lead Sponsor: National Cancer Center, Korea

Collaborator: Korean Cancer Study Group

Source National Cancer Center, Korea
Brief Summary

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.

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

Overall Status Recruiting
Start Date 2019-09-01
Completion Date 2023-12-31
Primary Completion Date 2022-12-31
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Response rate Response rate will be assessed at 8 weeks.
Secondary Outcome
Measure Time Frame
Progression-free survival 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.
Enrollment 38
Condition
Intervention

Intervention Type: Drug

Intervention Name: Anti-EGFR antibody in combination with weekly paclitaxel

Description: Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy

Arm Group Label: anti-EGFR

Other Name: GC-1118 in combination with weekly paclitaxel

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Hark K Kim, M.D.,Ph.D Principal Investigator National Cancer Center, Korea
Overall Contact

Last Name: Hark K Kim, M.D.,Ph.D

Phone: +82-31-920-2238

Email: [email protected]

Location
Facility: Status: Contact: National Cancer Center Hark K Kim, MD,PhD +82-31-920-2238 [email protected]
Location Countries

Korea, Republic of

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: National Cancer Center, Korea

Investigator Full Name: Hark Kyun Kim

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: anti-EGFR

Type: Experimental

Description: Participants will receive GC-1118 in combination with weekly paclitaxel.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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