NCT02568046

Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Symphogen A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Sym004	Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind specifically to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR).
DRUG	FOLFIRI	The standard FOLFIRI regimen consists of Irinotecan (180 mg/m\^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m\^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m\^2 IV bolus, then 2400 mg/m\^2 infused over 46 hours).

Timeline

• Start date: 2016-03-15
• Primary completion: 2017-05-15
• Completion: 2018-05-05
• First posted: 2015-10-05
• Last updated: 2019-03-26
• Results posted: 2019-01-09

Locations

8 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study