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

NCT07625423 | Recruiting Phase 1 DMC

• 1 other identifier: 2025(395)
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head & Neck Cancer; Nasopharyngeal Cancinoma (NPC)

Keywords

head and neck cancer; nasopharyngeal cancer; recombinant human endostatin adenovirus

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events, and clinically significant abnormal laboratory findings. Adverse events will be graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC), version 4.0. Safety evaluation will also include physical examination findings and environmental shedding monitoring related to intratumoral administration of EDS01.

  From signing informed consent through 1 month after the end of treatment (up to 16 weeks).

Secondary Outcomes (4)

• Objective response rate of target lesions

  From baseline until disease progression or end of treatment, whichever occurs first (up to 3 years).

• Disease control rate of target lesions

  From baseline until disease progression or end of treatment, whichever occurs first (up to 3 years).

• Overall objective response rate of all lesions

  From baseline until disease progression or end of treatment, whichever occurs first (up to 3 years).

• Time to progression (TTP)

  From enrollment until first documented disease progression; participants will be followed every 3 months after treatment until progression or death. Up to 3 years from enrollment.

Other Outcomes (1)

• Change in serum anti-adenovirus IgG

  From signing informed consent through 1 month after the end of treatment (up to approximately 16 weeks).

Study Arms (3)

EDS01 1.0×10^11 VP + Toripalimab

EXPERIMENTAL

Participants receive intratumoral EDS01 1.0×10\^11 viral particles (VP) on Days 0 and 7 plus toripalimab 240 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.

Drug: EDS01 1.0×10^11 VP + Toripalimab

EDS01 5.0×10^11 VP + Toripalimab

EXPERIMENTAL

Participants receive intratumoral EDS01 5.0×10\^11 viral particles (VP) on Days 0 and 7 plus toripalimab 240 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.

Drug: EDS01 1.0×10^12 VP + Toripalimab

EDS01 1.0×10^12 VP + Toripalimab

EXPERIMENTAL

Participants receive intratumoral EDS01 1.0×10\^12 viral particles (VP) on Days 0 and 7 plus toripalimab 240 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.

Drug: EDS01 5.0×10^11 VP + Toripalimab

Interventions

EDS01 1.0×10^11 VP + Toripalimab DRUG

Recombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 1.0×10\^11 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.

EDS01 1.0×10^11 VP + Toripalimab

EDS01 5.0×10^11 VP + Toripalimab DRUG

Recombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 5.0×10\^11 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.

EDS01 1.0×10^12 VP + Toripalimab

EDS01 1.0×10^12 VP + Toripalimab DRUG

Recombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 1.0×10\^12 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.

EDS01 5.0×10^11 VP + Toripalimab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to the study drugs. Lesions involving major blood vessels or nerves and therefore unsuitable for local injection.
• 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.
• Acute infection. Pregnant or breastfeeding women. Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, China, 610041, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Nasopharyngeal Neoplasms

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

nan lin, MD

CONTACT

+8618708305692; nanishard@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biotherapy Department, Deputy Director

Model Details: This is a single-center, open-label, dose-escalation cohort study in which participants are assigned to 3 planned cohorts. All participants receive intratumoral EDS01 in combination with toripalimab, and the cohorts differ by the planned dose level of EDS01. The study is designed to characterize the safety and tolerability of the combination across prespecified dose cohorts in patients with recurrent or metastatic head and neck tumors.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: June 4, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)