RecruitingPhase 2NCT07314294

Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients

A Randomized, Open-label, Phase II Study of EMB-01 in Patients With Recurrent/Metastatic Colorectal Cancer


Sponsor

Shanghai EpimAb Biotherapeutics Co., Ltd.

Enrollment

54 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called EMB-01 in people with colorectal cancer that has come back or spread. The cancer must originate from the left side of the colon or rectum and not be removable by surgery. **You may be eligible if...** - You are 18 or older - You have confirmed advanced or metastatic left-sided colorectal cancer with at least one measurable tumor - You have already tried at least one or two standard chemotherapy regimens (including fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab) and they stopped working - You are in generally good physical condition (ECOG score 0 or 1) - You can provide a tumor tissue sample **You may NOT be eligible if...** - Your tumor has certain genetic mutations (KRAS, NRAS, BRAF V600E, HER2, RET, or NTRK) - You have active brain metastases with symptoms - You have previously had serious skin reactions (Stevens-Johnson syndrome) or had prior combined anti-EGFR/cMET therapy - Your life expectancy is less than 3 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEMB-01 1600 mg administered once weekly throughout the study

Participants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) throughout the study.

DRUGEMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter

Participants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) for the first 6 weeks, followed by 1600 mg administered every 2 weeks (Q2W) thereafter.


Locations(2)

Beijing Cancer Hospital

Beijing, China

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07314294


Related Trials