Spots Global Cancer Trial Database for Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

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Trial Identification

Brief Title: Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

Official Title: An Open Label, Multi-Center Phase 1b/2a Trial Investigating Different Doses of Sym004 in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer Progressing After First-Line Therapy

Study ID: NCT02568046

Conditions

Metastatic Colorectal Cancer

Interventions

Sym004

FOLFIRI

Study Description

Brief 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).

Detailed Description: In the Phase 1b (Dose-Escalation) portion of the trial, patients will be sequentially enrolled to dose-escalation cohorts until establishment of the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of Sym004 in combination with FOLFIRI. The Phase 2a (Dose-Expansion) portion of the trial is expected to begin after establishing the RP2D. Note: In January 2017, the trial was terminated during Phase 1b and enrollment was prematurely discontinued. The primary objective changed to assess the safety of the treatment combination; collection of data for secondary and exploratory objectives was omitted.