- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05750290
CKD-702 Plus Irinotecan in Gastric Cancer
February 20, 2023 updated by: National Cancer Center, Korea
CKD-702 Plus Irinotecan as a ≥3L Therapy for Gastric and Gastroesophageal Junction Adenocarcinomas Overexpressing EGFR or MET
CKD-702 is a tetravalent bispecific IgG1 targeting hepatocyte growth factor receptor (MET) and epidermal growth factor receptor (EGFR).
The investigators will test a hypothesis that CKD-702 may augment the efficacy of biweekly irinotecan as a 3L or later therapy for gastric cancer overexpressing either MET or EGFR.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
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 Locations
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Failed 2 or more lines of chemotherapy
- Tumor overexpressing either MET or EGFR
- Measurable lesion
Exclusion Criteria:
- Prior treatment with anti-MET/EGFR bispecific antibody
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CKD-702 in combination with irinotecan
|
CKD-702 and irinotecan will be intravenously administered every 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best objective response rate
Time Frame: Through study completion, an average of 24 weeks
|
RECIST v1.1
|
Through study completion, an average of 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2022
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
February 9, 2023
First Submitted That Met QC Criteria
February 20, 2023
First Posted (Actual)
March 1, 2023
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 20, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- 100945
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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