drugset / Trial / NCT04880863

NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC

NCT04880863

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

EvaluationDrugModalityDoseRoute
Subject Naptumomab estafenatox Protein / enzyme biologic 15 ug/kg Intravenous
Background Docetaxel Small molecule
Background Obinutuzumab Monoclonal antibody 1000 mg Intravenous