drugset / Trial / NCT02205333
A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to determine the best dose of MEDI6469 that is safe and tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736 (durvalumab), or rituximab in participants with either advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 (durvalumab) will be tested with MEDI6469 in a set of participants with advanced solid tumors while rituximab will be tested with MEDI6469 in participants with DLBCL. MEDI6469 will be tested as monotherapy in participants with advanced solid tumors.
Timeline
- Start
- 2014-08-13
- Primary completion
- 2016-04-08
- Completion
- 2016-04-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | MEDI6469 | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | MEDI6469 | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | MEDI6469 | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 10 mg/kg | Intravenous |