drugset / Trial / NCT02568046

Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

NCT02568046

Phase 1/2 Terminated 10 enrolled Symphogen A/S
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1b/2a study investigating the safety and efficacy of Sym004, an investigational medicinal product (IMP), in combination with FOLFIRI (chemotherapy) when administered every second week (Q2W).

Timeline

Start
2016-03-15
Primary completion
2017-05-15
Completion
2018-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Sym004 Monoclonal antibody 9 mg/kg
Subject Sym004 Monoclonal antibody 12 mg/kg
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications