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Brief Title: Sym004 Versus Futuximab or Modotuximab in Patients With mCRC
Official Title: A Ph2, Randomized, Open-Label, Multicenter, Three-Arm Trial of Sym004 Versus Each of Its Component Futuximab and Modotuximab, in Patients With Chemotherapy-Refractory Metastatic Colorectal Carcinoma and Acquired Resistance to Anti-EGFR mAb
Study ID: NCT03549338
Brief Summary: This is a Phase 2, randomized, open-label, 3-arm trial in the ratio of 1:1:1 to either Sym004 (Arm A) versus each of its component monoclonal antibodies (mAbs), futuximab (Arm B) or modotuximab (Arm C), in genomically-selected patients with chemotherapy-refractory metastatic colorectal carcinoma (mCRC) and acquired resistance to anti-epidermal growth factor receptor (anti-EGFR) mAb therapy. The study is designed to evaluate the relative antitumor activity of each agent as assessed by imaging studies performed after 8 weeks of treatment.
Detailed Description: Following consent and prior to randomization, genomic analysis will be conducted on blood samples obtained from each potential patient. Triple-negative (TN) results as defined in trial eligibility criteria will be required for initial eligibility. Patients with TNmCRC will continue in the screening process. Once deemed fully eligible, patients will be randomized to Arm A, Arm B, or Arm C. Dosing cycles of 28 days will continue until documented disease progression (PD) or another criterion for discontinuation is met. Antitumor activity will be assessed at the end of every 2 cycles (every 8 weeks \[Q8W\]). At the End of Cycle 2 (EOC2) tumor assessment: * Patients assigned to Arm A (Sym004) with a documented objective response (OR) or stable disease (SD) will continue to receive Sym004; patients at the EOC2 with documented PD will be discontinued from study * Patients assigned to Arm B (futuximab) or Arm C (modotuximab) with a documented OR or SD will be crossed-over to receive Sym004; patients with documented PD at the EOC2 (or prior to the EOC2) will be offered the opportunity to crossover to receive Sym004 or will be discontinued from study To be considered evaluable for antitumor activity assessment, patients must have completed 2 cycles of dosing inclusive of EOC2 disease imaging studies and must have received any amount of their assigned investigational medicinal product (IMP) during that period, or have PD documented by imaging studies prior to the EOC2. Non-evaluable patients and patients discontinuing from study prior to the EOC2 for reasons other than documented PD will not be replaced. Note: In December 2018, the decision was made to terminate the trial and enrollment was prematurely discontinued. The primary, secondary, and exploratory objectives are no longer applicable. Only clinical safety-related evaluations will be conducted.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope - Comprehensive Cancer Center, Duarte, California, United States
Emory University Hospital, Atlanta, Georgia, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of North Carolina - Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Uniklinik Dresden, Dresden, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Asklepios Kliniken Altona, Hamburg, , Germany
Universitätsmedizin Mannheim, Mannheim, , Germany
Städtisches Klinikum München, München, , Germany
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Napoli, , Italy
Università degli Studi della Campania "Luigi Vanvitelli", Napoli, , Italy
Hospital del Mar, Barcelona, , Spain
Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, , Spain
Institut Català d'Oncologia, Barcelona, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
Name: Scott Kopetz, MD,PhD,FACP
Affiliation: The University of Texas MD Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR