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

NCT ID: NCT05812677

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2026-02-06

Brief Summary

20 participants are expected to be enrolled for this open，Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory Cervical and Endometrial Cancer.

Conditions

Cervical Cancer; Endometrial Cancer; Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R130 Treatment Group

Every 7-14 days,1-4 ml R130 （concentration of 1x10\^8 plaque-forming Units/mL,PFU/mL）will be injected intratumoral or Intraperitioneal in patients with relapsed/refractory cervical and endometrial Cancer.

Group Type: EXPERIMENTAL

Recombinant oncolytic herpes simplex virus type Ⅰ (R130)

Intervention Type: DRUG

R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11

Interventions

Recombinant oncolytic herpes simplex virus type Ⅰ (R130)

R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11

Intervention Type: DRUG

Other Intervention Names

Oncolytic virus Injection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Yunying Medical Technology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Pan

Role: CONTACT

pf@jxyymedtech.com

+86 13764868528

Facility Contacts

Jing Guo, Phd

Role: primary

jguo12@foxmail.com

+86 18817821547

Other Identifiers

SHSY-R130-CC

Identifier Type: -

Identifier Source: org_study_id