Phase 1 Study of Intratumoral Recombinant Human Endostatin Adenovirus EDS01 Combined with Toripalimab in Adults with Recurrent or Metastatic Head and Neck Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early antitumor effects of a new treatment combining recombinant human endostatin adenovirus injection EDS01 with toripalimab in adults who have recurrent or metastatic head and neck tumors, including nasopharyngeal carcinoma. These patients have previously been treated with platinum-based chemotherapy or cannot undergo further platinum treatment. This study is a Phase 1 trial conducted at a single center to explore this combination in patients with limited treatment options. Participants will be divided into three groups receiving different doses of EDS01 injected directly into an accessible tumor lesion on Days 0 and 7. In addition, toripalimab will be given intravenously at a fixed dose of 240 mg on Day 1 of each 21-day treatment cycle. Treatment may continue for up to four cycles unless the disease worsens or side effects become unacceptable. The study will assess different dose levels of EDS01 combined with toripalimab to determine safety and feasibility. During the study, participants will undergo clinical assessments, physical exams, laboratory tests, and imaging scans to monitor tumor response and detect any adverse events. Tumor response will be measured using standard criteria RECIST 1.1, focusing on objective response, disease control, and time to progression. Participants will be followed up every three months after treatment until disease progression or death. Additional tests include antibody monitoring and blood measurements related to the treatment. The total duration of follow-up may last up to three years.

Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors