drugset / Trial / NCT02665416
Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic activity of Selicrelumab in combination with vanucizumab or bevacizumab in participants with metastatic solid tumors not amenable to standard treatment. Part I (dose escalation) is designed to establish the maximum tolerated dose (MTD) of Selicrelumab in this combination. Part II (expansion) is intended to characterize the safety and tolerability of Selicrelumab in combination with bevacizumab among indication-specific cohorts and to confirm the recommended dose.
Timeline
- Start
- 2016-01-25
- Primary completion
- 2019-10-30
- Completion
- 2019-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Subject | Selicrelumab | Monoclonal antibody | — | Subcutaneous |
| Subject | Vanucizumab | Monoclonal antibody | 2 g | Intravenous |
Indications
No indication recorded.