Metastatic Colorectal Cancer Clinical Trial
Official title:
A Phase 3, Randomized, Open-Label, Multicenter Trial of Sym004 Versus Trifluridine/Tipiracil (TAS-102) in Patients With Chemotherapy-Refractory or Relapsed Metastatic Colorectal Carcinoma and Acquired Resistance to Anti-EGFR Monoclonal Antibody Therapy
This is a Phase 3, randomized, open-label, 2-arm trial designed to evaluate overall survival (OS) following treatment with Sym004, an investigational medicinal product (IMP), versus TAS-102 (trifluridine/tipiracil), a comparator (control) agent.
Randomization is in the ratio of 1:1 to either Sym004 (Arm A) or TAS-102 (Arm B) in
genomically-selected patients with chemotherapy-refractory or relapsed metastatic colorectal
carcinoma (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR)
monoclonal antibody (mAb) therapy.
Following consent, centralized genomic analysis will be conducted on blood samples obtained
from each potential patient. Double-negative (DN) results as defined in trial inclusion
criteria will be required for initial eligibility prior to randomization. Patients with
DNmCRC will continue in the screening process. Once deemed fully eligible, patients will be
randomized to either Arm A or Arm B (collectively referred to as protocol therapy).
Dosing cycles of 28 days with the assigned protocol therapy will continue until a
protocol-specified discontinuation criterion is met. Following treatment discontinuation,
patients will continue to be followed for OS.
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