MedTrace Logo

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

NCT07314294 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

EMB-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.

DRUG

EMB-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.

Sponsors & Collaborators

  • Shanghai EpimAb Biotherapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2027-12-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07314294 on ClinicalTrials.gov