drugset / Trial / NCT01995188
A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Participants With Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-small Cell Lung Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics of DNIB0600A in participants with platinum-sensitive ovarian cancer (PSOC) or Non-Squamous Non-small Cell Lung Cancer (NSCLC). The maximum tolerated dose of intravenously infused DNIB0600A in combination with carboplatin will be determined in escalating dose cohorts. The combination of DNIB0600A and carboplatin will then be evaluated with and without bevacizumab \[Avastin\] in three dose expansion cohorts.
Timeline
- Start
- 2013-12-16
- Primary completion
- 2016-11-09
- Completion
- 2016-11-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Lifastuzumab vedotin | Unknown | 1.2 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |