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

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

Trial Details

NCT ID
NCT07625423
Phase
PHASE1
Sponsor
West China Hospital
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • EDS01 1.0×10^11 VP + Toripalimab
  • EDS01 5.0×10^11 VP + Toripalimab
  • EDS01 1.0×10^12 VP + Toripalimab
Locations (sample)
  • Chengdu, China, China|30.66667,104.06667

Key Eligibility 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 …
  • Not suitable for surgery or radiotherapy. At least 1 target lesion suitable for intratumoral injection of recombinant human endostatin adenovirus i…
  • At least 1 measurable lesion with diameter ≥2 cm on imaging, according to RECIST version 1.1.

For full eligibility, visit ClinicalTrials.gov.

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