Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatmen
This single-center, Phase 1 study is evaluating the safety, tolerability, and preliminary antitumor activity of recombinant human endostatin adenovirus injection (EDS01) given by intratumoral injection in combination with toripalimab in adults with recurrent or metastatic head and neck tumors, including nasopharyngeal
| Condition(s) | Head & Neck Cancer, Nasopharyngeal Cancinoma (NPC) |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This single-center, Phase 1 study is evaluating the safety, tolerability, and preliminary antitumor activity of recombinant human endostatin adenovirus injection (EDS01) given by intratumoral injection in combination with toripalimab in adults with recurrent or metastatic head and neck tumors, including nasopharyngeal carcinoma, whose disease has progressed after platinum-based systemic therapy or who are not suitable for further platinum treatment. A total of 9 participants will be enrolled in 3 planned dose groups of EDS01. EDS01 will be injected directly into an accessible tumor lesion on Days 0 and 7, and toripalimab 240 mg will be administered intravenously on Day 1 of each treatment cycle for up to 4 cycles, unless disease progression or unacceptable toxicity occurs. The study will e |
| Who can participate | Inclusion Criteria: Adults aged 18 to 65 years. Histologically or cytologically confirmed recurrent or metastatic head and neck tumor. Previously received at least 1 standard platinum-based systemic chemotherapy regimen for recurrent/metastatic disease, or had platinum-insensitive or platinum-intolerant disease after prior curative-intent treatment. Not suitable for surgery or radiotherapy. At least 1 target lesion suitable for intratumoral injection of recombinant human endostatin adenovirus injection. At least 1 measurable lesion with diameter ≥2 cm on imaging, according to RECIST version 1.1. No chemotherapy, radiotherapy, biologic antitumor therapy, or antiviral therapy within 4 weeks before enrollment. Estimated life expectancy of at least 12 weeks. ECOG performance status 0 to 1. Mal |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | West China Hospital |
| Locations | Chengdu, China, China |
| Start date | 2026-03-27 |
| NCT ID | NCT07625423 |
| Official listing | https://clinicaltrials.gov/study/NCT07625423 |