Oncolytic virus injection for treating relapsed cervical and endometrial cancer

A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Cervical and Endometrial Cancer

This study is testing a new virus treatment for people with cervical and endometrial cancer that has come back after other treatments to see if it can help them.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shanghai Yunying Medical Technology (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05812677 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a recombinant oncolytic herpes simplex virus type Ⅰ (R130) in patients with relapsed or refractory cervical and endometrial cancer. The study aims to enroll 20 participants who have either failed standard treatments or are unwilling to pursue further antitumor therapies. Participants will receive intratumoral or intraperitoneal injections of the virus, and their responses will be monitored to assess the treatment's effectiveness. The trial is designed as an open-label, single-arm study, focusing on patients with measurable lesions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with histologically confirmed cervical or endometrial cancer who have experienced treatment failure.

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

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with advanced cervical and endometrial cancers that have not responded to standard therapies.

How similar studies have performed: While oncolytic virus therapies are an emerging field, this specific approach using R130 in cervical and endometrial cancers is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Patients with cervical cancer or endometrial cancer clearly diagnosed by histology and/or cytology.
2. Failure of standard treatment or patient unwillingness to receive other antitumor therapy.
3. Age 18 to 75 years.
4. Subjects with ECoG score of 0-2.
5. Expected survival of 3 months or more.
6. Have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral or intraperitoneal drug delivery.
7. Subjects must have appropriate organ function, and laboratory tests during the screening period must meet the following requirements: a) absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets (PLT) ≥ 80 × 109/L, and hemoglobin (Hb) ≥ 85 g/L; b) serum creatinine (Cr) and blood urea nitrogen (BUN) within 1.5 times the upper limit of normal values; c) serum c) serum total bilirubin (TBIL) ≤ 2 times the upper limit of normal values; d) glutamic aminotransferase (ALT) and glutamic oxalacetic aminotransferase (AST) ≤ 2.5 times the upper limit of normal values; subjects with liver metastases do not exceed 5 times the upper limit of normal values; e) activated partial thromboplastin time (APTT), prothrombin time (PT) within 1.5 times the upper limit of normal values.
8. Any treatment for malignancy, including radiotherapy, chemotherapy and biological agents, must be discontinued 28 days prior to R130 treatment.
9. Eligible patients of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for the duration of the trial and for at least 180 days after the last dose; female patients of childbearing potential must have a negative urine pregnancy test within 7 days prior to enrollment.
10. Subjects voluntarily sign an informed consent form and are in good compliance.

Exclusion Criteria:

1. Have had any serious adverse reactions associated with immunotherapy.
2. Subjects with any severe and/or uncontrolled disease, including: a) poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); b) suffering from class I or higher myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) active or uncontrolled severe infection (≥ CTCAE grade 2 infection); d) Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency; e) Urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification \> 1.0 g.
3. Patients with past history of type I diabetes mellitus or HIV.
4. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy.
5. Patients with symptomatic primary or metastatic brain tumors.
6. Patients with active tuberculosis and a strong positive OT test.
7. Patients with active bleeding or severe coagulation dysfunction.
8. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose.
9. Have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy.
10. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance.
11. Patients who have undergone surgery of grade 3 or higher or whose surgical wounds have not healed within 4 weeks prior to enrollment.
12. Participation in other clinical trials within four weeks prior to enrollment.
13. Subjects who, in the judgment of the investigator, are unsuitable for participation in this trial for any reason.

Where this trial is running

Shanghai, Shanghai

• Shanghai Tenth People's Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Feng Pan

Conditions Cervical Cancer; Endometrial Cancer; Advanced Cancer; Oncolytic virus; Herpes simplex virus typeⅠ; Immunotherapy