drugset / Trial / NCT04880863
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC
NaSingle-groupOpen-labelTreatment
Summary
Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP), following Obinutuzumab Pretreatment, on Days -13 and -12. NAP will be administered on Days 1-4 of treatment cycles 1-6, followed by docetaxel on Day 5. Starting cycle 7, NAP at a higher dose will be administered on Day 1 only and docetaxel on Day 2, in 21 days treatment cycles. When NAP is administered as monotherapy and not earlier than cycle 7, NAP will be administered on Day 1 only and cycles will be of 28 days treatment cycle.
Timeline
- Start
- 2021-10-26
- Primary completion
- 2024-01-30
- Completion
- 2024-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naptumomab estafenatox | Protein / enzyme biologic | 15 ug/kg | Intravenous |
| Background | Docetaxel | Small molecule | — | — |
| Background | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |