Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: 1. Able to understand and willing to sign the informed consent form (ICF). 2. Male or female aged ≥ 18 years. 3. Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor from splenic flexure to rectum) with at least one measurable lesion according to RECIST v1.1. 4. ECOG performance status ≤ 1. 5. Willing to provide a fresh tumor biopsy sample or a stored sample obtained within the past 2 years.If no eligible archived tumor tissue sample is available and the patient's clinical condition is not suitable for biopsy, the patient may still be allowed to participate in screening upon confirmation and agreement between the investigator and the sponsor. 6. Adequate organ function prior to the first study treatment. 7. Prior anti-cancer treatment: 1. Must have progressed on or been intolerant to at least first- or second-line systemic therapy for metastatic colorectal cancer. Prior therapy must include fluoropyrimidine