Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:55 AM
Study NCT ID:
NCT07314294
Status:
RECRUITING
Last Update Posted:
2026-03-03
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients
Sponsor:
Shanghai EpimAb Biotherapeutics Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Phase II Study of EMB-01 in Patients With Recurrent/Metastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is testing different dosing schedules of EMB-01 in patients with advanced colorectal cancer whose disease has recurrent or progressed on previous treatments. Patients will be randomly assigned to one of two dosing schedules: EMB-01 once weekly, or once weekly for 6 weeks then every two weeks.
Detailed Description:
This is a randomized, open-label Phase II dose-optimization study of EMB-01 in patients with metastatic colorectal cancer (CRC). The study will enroll patients with recurrent/metastatic KRAS/BRAF wild-type left-sided CRC who have progressed, relapsed, or become intolerant after first- or second-line systemic therapy. Patients will be stratified by prior anti-EGFR therapy and randomized 1:1 into two groups.
Group 1 will receive EMB-01 1600 mg once weekly (QW). Group 2 will receive EMB-01 1600 mg QW for the first 6 weeks, followed by 1600 mg once every two weeks (Q2W).
Tumor assessments will follow RECIST v1.1 using CT and/or MRI. Baseline imaging will be performed within 28 days before enrollment. During the study, imaging and efficacy assessments will occur every 6 weeks for the first 12 cycles, and every 3 cycles thereafter. All imaging procedures must be consistent with baseline. Assessments will be performed by the investigator, with retrospective independent review if needed.
Group 1 will receive EMB-01 1600 mg once weekly (QW). Group 2 will receive EMB-01 1600 mg QW for the first 6 weeks, followed by 1600 mg once every two weeks (Q2W).
Tumor assessments will follow RECIST v1.1 using CT and/or MRI. Baseline imaging will be performed within 28 days before enrollment. During the study, imaging and efficacy assessments will occur every 6 weeks for the first 12 cycles, and every 3 cycles thereafter. All imaging procedures must be consistent with baseline. Assessments will be performed by the investigator, with retrospective independent review if needed.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: