Actively Recruiting
Randomized Open-label Phase II Study of EMB-01 in Patients with Recurrent or Metastatic Colorectal Cancer
Led by Shanghai EpimAb Biotherapeutics Co., Ltd. · Updated on 2026-03-03
54
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different dosing schedules of EMB-01 in patients with advanced metastatic colorectal cancer that has returned or worsened after previous treatments. This Phase II randomized, open-label study focuses on patients with recurrent or metastatic KRASBRAF wild-type left-sided colorectal cancer who have progressed or become intolerant to first- or second-line systemic therapies. The study aims to optimize the dosing of EMB-01 based on tumor response and safety assessments. Participants will be randomly assigned to one of two groups. One group will receive EMB-01 at 1600 mg once weekly throughout the study. The other group will receive 1600 mg once weekly for the first 6 weeks, then switch to 1600 mg every two weeks. Tumor assessments using CT or MRI scans will be conducted at baseline and every 6 weeks for the first 12 cycles, then every 3 cycles thereafter to evaluate response according to RECIST criteria. During the study, participants will undergo imaging, efficacy assessments, and safety monitoring including tracking adverse events. Assessments will be performed by investigators with independent review if needed. The primary outcomes include the objective response rate up to 48 months and the number of participants with adverse events. Safety follow-up will continue for 30 days after the last dose. The study is expected to last up to several years, allowing detailed evaluation of EMB-01 dosing schedules.
CONDITIONS
Brief 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 the informed consent form
- Male or female aged 18 years or older
- Histologically or cytologically confirmed 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 tumor biopsy or a stored sample obtained within the past 2 years
- Adequate organ function before starting treatment
- Progressed on or intolerant to at least first- or second-line systemic therapy including fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab with or without cetuximab
- Discontinued other 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 study treatment
- Women of childbearing potential and male partners must use contraception during the 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 mutations affecting treatment
- 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 before screening
- Idiopathic pulmonary fibrosis, active or chronic lung disease, or interstitial lung disease
- History of severe skin reactions or 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
- Any condition making participation not in patient’s best interest or likely to interfere with assessments or treatment adherence
Research Team
M
Mingfei Zhang
J
Junqiang He
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