NCT07625423RecruitingPhase 1
Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors
A Phase I Clinical Trial of Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) Combined With Toripalimab for the Treatment of Recurrent or Metastatic Head and Neck Tumors
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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 evaluate treatment-related adverse events as well as preliminary efficacy outcomes, including tumor response, disease control, and time to progression, using clinical assessments, laboratory tests, imaging, and follow-up after treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 27 Mar 2026
- Start date
- 27 Mar 2026
- Primary completion date
- 30 Mar 2028
- Lead sponsor
- West China Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT07625423
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 9
- From 27 Mar 2026 to the primary completion date, 30 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving radiotherapy to the study lesion at the same time. Prior anti-angiogenic therapy. Receiving immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes at a dose greater than prednisone 10 mg/day (or equivalent) within 2 weeks before enrollment.
- Active autoimmune disease or history of autoimmune disease. Congenital or acquired immunodeficiency. Risk of major nasopharyngeal hemorrhage or deep nasopharyngeal ulceration. Severe coagulation disorder or bleeding tendency. Severe uncontrolled medical disease or myocardial infarction within 3 months before enrollment.
Other illness
- Known allergy to the study drugs. Lesions involving major blood vessels or nerves and therefore unsuitable for local injection.
- Acute infection. Pregnant or breastfeeding women. Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Who the study is looking for
- 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. Male or female participants of childbearing potential must agree to use reliable contraception during treatment and for at least 6 months after treatment.
- Recovery of prior treatment-related toxicities to NCI CTCAE grade 1 or baseline, with screening laboratory results within 1 week before enrollment meeting protocol requirements: ANC ≥1.5×10\^9/L, platelet count ≥80×10\^9/L, total bilirubin ≤1.5 × ULN, ALT and AST ≤2 × ULN, and coagulation parameters ≤1.25 × ULN.
- Willing and able to provide written informed consent.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.