drugset / Trial / NCT06935188
Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC
Phase 2
Recruiting
98 enrolled
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a single center, randomized controlled, prospective phase II clinical trial to evaluate the efficacy and safety of cetuximab combined with dalpicilib compared to cetuximab monotherapy in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. The participants would receive cetuximab combined with dalpicilib or cetuximab monotherapy until termination criteria are met.
Timeline
- Start
- 2025-04-17
- Primary completion
- 2028-12-31
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Comparator | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Dalpiciclib | Small molecule | 150 mg | Oral |