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Sym004 with FOLFIRI in Metastatic Colorectal Cancer
NCT02568046Phase 2
Key facts
- Status
- Terminated
- Start
- Mar 2016
- Primary completion
- May 2017
- Countries
- 2
- Sponsor
- Symphogen
- Modality
- Bispecific Antibodies, Monoclonal Antibodies
- Conditions
- metastatic colorectal cancer (mCRC)
01
Overview
Phase 2, open-label trial of futuximab + modotuximab in metastatic colorectal cancer (mCRC) (3 arms), sponsored by Symphogen. Primary endpoint: Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence at 15 months. Started Mar 2016; status: terminated.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Sym004 12 mg/kg + FOLFIRI
Sym004 12 mg/kg Q2W + FOLFIRI
Sym004 9 mg/kg + FOLFIRI
Sym004 9 mg/kg Q2W + FOLFIRI
Sym004 (RP2D) + FOLFIRI
Sym004 at Recommended Phase 2 Dose + FOLFIRI
03
Who it enrols
Patients with metastatic colorectal cancer, KRAS/NRAS wild type, who have failed first-line oxaliplatin/fluoropyrimidine therapy and are eligible for FOLFIRI.
04
Endpoints
Primary
Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence
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