Using a new oncolytic virus to treat late-stage solid tumors

The Application of Novel Oncolytic Virus in Late Stage Solid Tumors

This study is testing a new virus treatment for people with late-stage solid tumors, like certain types of skin cancer, to see if it can help shrink tumors while working alongside other therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06080984 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of novel oncolytic viruses in patients with late-stage solid tumors, specifically targeting advanced squamous cell carcinoma of the head and neck, malignant melanoma, and soft tissue sarcomas. Oncolytic viruses selectively infect and destroy tumor cells while sparing normal cells, potentially enhancing anti-tumor immune responses. The study aims to assess the therapeutic benefits of these viruses, particularly when combined with other treatments like chemotherapy and immunotherapy. Participants will receive either Oncolytic Virus SDJ001 or YD06-1 as part of their treatment regimen.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced solid tumors such as squamous cell carcinoma of the head and neck, malignant melanoma, or soft tissue sarcomas who have failed previous treatments.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, effective treatment option for patients with late-stage solid tumors who have exhausted standard therapies.

How similar studies have performed: Previous studies have shown promising results with oncolytic virus therapies, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients: ≥18 years.
2. a)Patients with confirmed advanced squamous cell carcinoma of the head and neck (including nasopharynx) who meet the following criteria: Patients who have failed standard second-line treatment. Tumors that cannot be cured through local treatment (surgery or definitive radiation therapy).

   b)Patients with stage III malignant melanoma who are not eligible for surgical resection, or patients with stage IV malignant melanoma, who have failed at least two lines of standard treatment (including chemotherapy, immunotherapy or targeted therapy).

   c)Patients with locally unresectable or metastatic advanced soft tissue sarcomas, who have failed prior systemic treatments.
3. ECOG performance status score: 0-1.
4. Expected survival ≥3 months.
5. Time since the last chemotherapy/radiotherapy/surgery is more than 28 days.
6. Adequate organ function, as defined by the following criteria within 14 days before enrollment:

   Hematology: Hemoglobin ≥90g/L (without blood transfusion in the last 14 days); Neutrophil count \>1.5×10\^9/L; Platelet count ≥80×10\^9/L.

   Biochemistry: Total bilirubin ≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN; if there is liver metastasis, ALT or AST ≤5×ULN; Estimated glomerular filtration rate ≥60ml/min (Cockcroft-Gault formula).

   Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%.
7. Patients with injectable lesions (those suitable for direct injection or injection with the assistance of medical imaging), defined as follows: at least one injectable lesion in the skin, mucous membrane, subcutaneous tissue, or lymph node with a longest diameter ≥10 mm, or multiple injectable lesions with a total longest diameter ≥10 mm
8. No continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical intervention, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) Grade 1.
9. Signed written informed consent Subjects must sign a written informed consent form approved by the competent authority and the research institution and date it. The informed consent form must be signed before any protocol-related procedures (not part of the subject's routine medical care) are conducted.

Subjects must be willing and able to comply with the scheduled visits, treatment regimen, laboratory tests, and other requirements of the study.

Exclusion Criteria:

1. Participated in another drug clinical trial within the past 4 weeks.
2. Tumor located near major blood vessels or the trachea.
3. Has poorly controlled clinical heart symptoms or diseases, such as NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within the past year, clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention.
4. For female subjects: pregnant or lactating women.
5. Persistent or active infections, including but not limited to: active pulmonary tuberculosis, positive HIV (Human Immunodeficiency Virus) antibodies, positive HBsAg (Hepatitis B Surface Antigen), positive HBcAb (Hepatitis B Core Antibody), and positive HCV (Hepatitis C Virus) antibody test results.

   1. Participants who are positive for HBsAg and/or HBcAb must also provide baseline HBV DNA results and undergo HBV DNA monitoring during the treatment according to the protocol.
   2. Participants with HBV DNA results of 10\^4 copies/ml or ≥ 2000 IU/mL and any of the following conditions should be excluded: 1) positive results for HBsAg and/or HBeAg; 2) positive results for HBcAb and negative results for all others.
   3. Patients with a positive HCV antibody test result are only ineligible for study participation if their HCV RNA test result is positive..
6. Has a history of substance abuse that cannot be discontinued or has psychiatric disorders.
7. Has any active autoimmune disease or a history of autoimmune disease, including but not limited to uveitis, enteritis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has completely resolved in adulthood without the need for intervention may be included; subjects with asthma requiring bronchodilators for medical intervention cannot be included.
8. Patients who have used systemic corticosteroids (\>10g/day of prednisone or an equivalent dose) or other immunosuppressive drugs in the 4 weeks prior to the initial administration of the study drug will be excluded.
9. Has a history of substance abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug abuse.
10. Known allergy, hypersensitivity reaction, or intolerance to oncolytic virus research (including any excipients). A history of severe allergies to any drugs, foods, or vaccines, such as anaphylactic shock, angioedema, respiratory distress, purpura, thrombocytopenic purpura, or localized allergic necrotizing reaction (Arthus reaction), etc.
11. Female subjects with pregnancy plans during the screening period or male subjects with partners who have pregnancy plans.
12. Has accompanying diseases judged by the investigator to be seriously harmful to patient safety or affecting the patient's completion of the study.
13. Patients who have undergone major surgery other than diagnosis or have unhealed wounds, ulcers, or fractures within the 28 days prior to the initial administration of the investigational drug will be excluded. For patients with lesion rupture, screening may be considered, and the eligibility will be jointly assessed by the investigator and the sponsor, depending on the specific circumstances of the rupture. The injection site should be as far away from the rupture site as possible, and during the treatment period, rupture-related adverse events should not be recorded as investigational drug-related adverse events.
14. During the course of the study, the use of drugs against HSV, including but not limited to acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, and cidofovir, may be required.
15. Patients with episodes of oral herpes (cold sores) may present with small, bead-like, tense vesicles on or around the lips during the initial outbreak, typically measuring approximately 0.5 to 1.5 centimeters in size. These vesicles may also appear in the nose, ear, or finger areas and are often associated with significant pain. Recurrent oral herpes typically presents as ulcers above the vermilion border of the lip (lip herpes) and occasionally as ulcers above the hard palate mucosa.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Xingchen Peng — West China Hospital
• Study coordinator: Xingchen Peng

Conditions Malignant Tumor; Solid Tumors; Oncolytic Virus