EMD 521873 in Advanced Solid Tumors, MTD Finding
Summary
Primary trial objective in this three arm trial is to assess the safety and tolerability of EMD 521873, and to determine whether the maximum tolerated dose (MTD) is reached with EMD 521873 doses of up to 1.5 mg/kg given alone or in combination with fixed, low-dose cyclophosphamide (CPA) in patients with metastatic or locally advanced solid tumors or B-cell non-Hodgkin lymphoma. Secondary objectives are to evaluate pharmacokinetic, immunogenicity, overall and best clinical response, changes in tumor marker levels, survival and biological/immune responses to EMD 521873. A total of 78 patients are planned. Patients will remain on the dose throughout the trial. It is intended to administer 3 cycles (21 d each, or until progression or a xxx line therapy becomes necessary.
Timeline
- Start
- 2006-12
- Primary completion
- 2011-02
- Completion
- 2012-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EMD 521873 | Protein / enzyme biologic | 0.075 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 0.15 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 0.225 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 0.3 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 0.45 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 0.6 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 0.9 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 1.2 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 1.5 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 1.8 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 2.1 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 2.5 mg/kg | — |
| Subject | EMD 521873 | Protein / enzyme biologic | 3 mg/kg | — |