OncoMatch/Clinical Trials/NCT07625423
Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors
Is NCT07625423 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1 trial studies multiple treatments including EDS01 1.0×10^11 VP + Toripalimab and EDS01 5.0×10^11 VP + Toripalimab for head & neck cancer.
Treatment: EDS01 1.0×10^11 VP + Toripalimab · EDS01 5.0×10^11 VP + Toripalimab · EDS01 1.0×10^12 VP + Toripalimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IV
recurrent or metastatic head and neck tumor; not suitable for surgery or radiotherapy; at least 1 measurable lesion with diameter ≥2 cm on imaging, according to RECIST version 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy — recurrent/metastatic disease
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
Cannot have received: anti-angiogenic therapy
Prior anti-angiogenic therapy
Lab requirements
Blood counts
anc ≥1.5×10^9/l, platelet count ≥80×10^9/l
Liver function
total bilirubin ≤1.5 × uln, alt and ast ≤2 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07625423 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-angiogenic therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required.
Is there an age limit?
Yes. Patients must be 65 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages