drugset / Trial / NCT07628062
Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation
RandomizedParallel-groupOpen-labelTreatment
Summary
This Phase 2a/2 study evaluates the safety, tolerability, and efficacy of neoadjuvant and adjuvant NAI, hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel in participants with locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). The study includes a Phase 2a safety lead-in followed by a randomized Phase 2 comparison of a de-intensified experimental chemoradiation approach versus standard-of-care chemoradiation.
Timeline
- Start
- 2026-07-22
- Primary completion
- 2030-12-31
- Completion
- 2031-06-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | IBRX-042 | Unknown | — | Subcutaneous |
| Subject | N-803 | Protein / enzyme biologic | 1.2 mg | Subcutaneous |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |