Back to resultsCKD-702 Plus Irinotecan in Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-702 in combination with irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
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
Sites / Locations
- National Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CKD-702 in combination with irinotecan
Arm Description
Outcomes
Primary Outcome Measures
Best objective response rate
RECIST v1.1
Secondary Outcome Measures
Full Information
NCT ID
NCT05750290
First Posted
February 9, 2023
Last Updated
February 20, 2023
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT05750290
Brief Title
CKD-702 Plus Irinotecan in Gastric Cancer
Official Title
CKD-702 Plus Irinotecan as a ≥3L Therapy for Gastric and Gastroesophageal Junction Adenocarcinomas Overexpressing EGFR or MET
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CKD-702 in combination with irinotecan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CKD-702 in combination with irinotecan
Intervention Description
CKD-702 and irinotecan will be intravenously administered every 2 weeks.
Primary Outcome Measure Information:
Title
Best objective response rate
Description
RECIST v1.1
Time Frame
Through study completion, an average of 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hark K Kim, MD,PhD
Phone
+82-31-920-2238
Email
hkim@ncc.re.kr
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hark K Kim, MD,PhD
Phone
+82-31-920-2238
Email
hkim@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Hyegyung Chang, RN
Phone
+82-31-920-2233
Email
jhk@ncc.re.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CKD-702 Plus Irinotecan in Gastric Cancer
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