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

Sponsor
Shanghai EpimAb Biotherapeutics Co., Ltd.
Study ID
NCT07314294
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EMB-01 1600 mg administered once weekly throughout the study — DRUG
    Participants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) throughout the study.
  • EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jan 2, 2026
Start date
Dec 18, 2025
Status verified
Feb 2026
Primary completion
Dec 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EMB-01 1600 mg once weekly (QW)
    EMB-01 1600 mg administered once weekly throughout the study
  • Experimental: EMB-01 1600 mg once weekly (QW) for 6 weeks, then 1600 mg every 2 weeks (Q2W)
    EMB-01 1600 mg once weekly for the first 6 weeks, then 1600 mg every 2 weeks thereafter

Primary Outcome Measure

Objective response rate [ Time Frame: Drom the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months ]

Central Contacts

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