drugset / Trial / NCT03549338
Sym004 Versus Futuximab or Modotuximab in Patients With mCRC
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-11-29
- Primary completion
- 2019-03-01
- Completion
- 2019-03-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Futuximab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Modotuximab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Sym004 | Monoclonal antibody | 6 mg/kg | — |