drugset / Trial / NCT04091867
sEphB4-HSA With RT+Chemo or Cetux in Patients With Intermediate to High Risk LAHNSCC
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I dose-escalation study of sEphB4-HSA in combination with chemotherapy, cetuximab and radiotherapy (RT). The purpose is to estimate the maximum tolerated dose (MTD) that can be administered concurrently with Cetuximab and radiation in patients with locally advanced, Stage III or IV A-B squamous cell carcinomas of the head or neck with a history of at least ten pack-years of smoking.
Timeline
- Start
- 2020-01-06
- Primary completion
- 2021-05-14
- Completion
- 2022-10-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sEphB4-HSA | Protein / enzyme biologic | 10 mg/kg | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Background | Cisplatin | Other / unclassified | — | — |