Study of Xevinapant With Radiation and Chemotherapy for Patients With Head and Neck Cancer
Summary
The goal of this clinical trial is to determine the best safe dose of xevinapant that can be given in combination with chemotherapy and radiation in patients with head and neck cancer. Up to 4 doses of xevinapant will be tested in the dose escalation portion of the study. After the best safe dose is found during escalation, an additional group of participants will be enrolled at that dose to learn more about the treatment combination (dose expansion). The main question\[s\] it aims to answer are: * what is the maximum safe dose that can be given * what dose should be used in subsequent (phase 2) trials Participants will receive xevinapant in combination with paclitaxel and carboplatin chemotherapy and radiation. Treatment will be given in 3-week cycles for 3 cycles.
Timeline
- Start
- 2024-01-24
- Primary completion
- 2025-05-12
- Completion
- 2025-05-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Xevinapant | Small molecule | 50 mg | Oral |
| Subject | Xevinapant | Small molecule | 100 mg | Oral |
| Subject | Xevinapant | Small molecule | 150 mg | Oral |
| Subject | Xevinapant | Small molecule | 200 mg | Oral |
| Background | Carboplatin | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |