NCT05750290

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

February 9, 2023

Last Update Submit

February 20, 2023

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Best objective response rate

    RECIST v1.1

    Through study completion, an average of 24 weeks

Study Arms (1)

CKD-702 in combination with irinotecan

EXPERIMENTAL
Drug: CKD-702 in combination with irinotecan

Interventions

CKD-702 in combination with irinotecanDRUG

CKD-702 and irinotecan will be intravenously administered every 2 weeks.

CKD-702 in combination with irinotecan

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Failed 2 or more lines of chemotherapy
  • Tumor overexpressing either MET or EGFR
  • Measurable lesion

You may not qualify if:

  • Prior treatment with anti-MET/EGFR bispecific antibody

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Central Study Contacts

Hark K Kim, MD,PhD

CONTACT

+82-31-920-2238hkim@ncc.re.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

March 1, 2023

Study Start

December 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)