Actively Recruiting
Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients
Led by Shanghai EpimAb Biotherapeutics Co., Ltd. · Updated on 2026-03-03
54
Participants Needed
2
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Male or female aged 18 years or older
- Diagnosed with unresectable or metastatic left-sided colorectal cancer with at least one measurable lesion
- ECOG performance status of 0 or 1
- Willing to provide a fresh or stored tumor biopsy sample within past 2 years
- Adequate organ function before first treatment
- Progressed on or intolerant to at least first- or second-line systemic therapy including fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, and bevacizumab with or without cetuximab
- Discontinued any anti-cancer therapies at least 4 weeks or 5 half-lives before first study treatment
- Stopped local radiotherapy or oral fluoropyrimidines at least 2 weeks before first treatment; no therapeutic radiopharmaceuticals within 8 weeks before first dose
- Women of childbearing potential and male partners must use contraception during study and for 3 months after last dose
You will not qualify if you...
- Presence of KRAS/NRAS exon 2, 3, 4 mutations, BRAF V600 mutation, HER2 positivity, RET fusion, NTRK fusion, or other relevant mutations
- Life expectancy less than 3 months
- Residual adverse events from prior therapy greater than grade 1
- Primary CNS malignancy or symptomatic CNS metastases
- Pregnant or breastfeeding women
- Major surgery within 28 days prior to screening
- Idiopathic pulmonary fibrosis, active or chronic inflammatory lung disease, or history of interstitial lung disease
- History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or severe skin infections
- Prior dual anti-EGFR and cMET therapy or bispecific antibody-drug conjugates
- Prior EGFR inhibitor therapy stopped due to severe skin toxicity
- Other significant medical or psychiatric conditions that may interfere with study participation
- Any condition deemed by investigator to interfere with assessments or treatment safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
2
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, China
Not Yet Recruiting
Research Team
M
Mingfei Zhang
CONTACT
J
Junqiang He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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