NCT07154108

Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer

A Phase I, Open-label, Two-cohort Study of Recombinant Human Endostatin Adenovirus in Combination With Immune Checkpoint Inhibitors in Patients With Recurrent or Metastatic Head and Neck Cancer or Esophageal Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, open-label, dual-cohort clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of intratumoral injection of recombinant human endostatin adenovirus in combination with a PD-1 inhibitor in patients with recurrent or metastatic head and neck cancer, or in patients with esophageal squamous cell carcinoma (ESCC) with superficial lymph node metastasis.

Detailed description

Cohort A will enroll patients with recurrent or metastatic head and neck cancer. Cohort B will enroll patients with ESCC with superficial lymph node metastasis. Both cohorts will receive intratumoral injection of recombinant human endostatin adenovirus combined with intravenous an immune checkpoint inhibitor. The primary objectives are to assess the safety profile, incidence of dose-limiting toxicities (DLTs), and treatment-related adverse events (TRAEs) of the combination therapy. The secondary objectives include evaluation of objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Each cohort plans to enroll approximately 20 patients, with a total of 40 participants.

Conditions

• Esophageal Cancer
• Head and Neck Cancer (H&Amp;Amp;Amp;N)

Interventions

Type	Name	Description
BIOLOGICAL	recombinant human endostatin adenovirus	Recombinant Human Endostatin Adenovirus: Administered via intratumoral injection twice every 3 weeks for a total of eight doses, or until disease progression, the occurrence of unacceptable toxicity, or death from any cause, whichever occurs first.
DRUG	PD-1 Inhibitor	PD-1 inhibitor: Administered via intravenous infusion once every 3 weeks.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: China