CKD-702 Plus Irinotecan in Gastric Cancer
Sponsor
National Cancer Center, Korea (Other)
Overall Status
Recruiting
CT.gov ID
NCT05750290
Collaborator
(none)
40
1
1
37
1.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CKD-702 Plus Irinotecan as a ≥3L Therapy for Gastric and Gastroesophageal Junction Adenocarcinomas Overexpressing EGFR or MET
Actual Study Start Date
:
Dec 1, 2022
Anticipated Primary Completion Date
:
Dec 31, 2024
Anticipated Study Completion Date
:
Dec 31, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CKD-702 in combination with irinotecan
|
Drug: CKD-702 in combination with irinotecan
CKD-702 and irinotecan will be intravenously administered every 2 weeks.
|
Outcome Measures
Primary Outcome Measures
- Best objective response rate [Through study completion, an average of 24 weeks]
RECIST v1.1
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Cancer Center | Goyang | Gyeonggi | Korea, Republic of | 10408 |
Sponsors and Collaborators
- National Cancer Center, Korea
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT05750290
Other Study ID Numbers:
- 100945
First Posted:
Mar 1, 2023
Last Update Posted:
Mar 1, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms: