EGFR-targeted Therapy for Gastric Cancer

Adenocarcinoma of the Stomach Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04077255
• Other study ID #: 31973
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: National Cancer Center, Korea
• Contact: Hark K Kim, M.D.,Ph.D
• Phone: +82-31-920-2238
• Email: hkim[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Stomach

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Korean Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Response rate will be assessed using CT/MRI according to RECIST v1.1.	Response rate will be assessed at 8 weeks.
Secondary	Progression-free survival	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.