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Status unknownNCT05886075Updated Jun 2, 2023

A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Advanced Solid Tumors

An Early Phase 1 interventional study of Recombinant oncolytic herpes simplex virus type 1 (R130) in Lung Cancer, Bronchial Cancer and Non Small Cell Lung Cancer, sponsored by Shanghai Yunying Medical Technology. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-02.

Sponsored by Shanghai Yunying Medical Technology · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

24 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 advanced solid tumors.

02

Conditions studied

  • Lung Cancer
  • Bronchial Cancer
  • Non Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Sarcoma
  • Colorectal Cancer
  • Gastric Cancer
  • Liver Cancer
  • Breast Cancer
  • Pancreatic Cancer
  • Head and Neck Cancer
  • Ovarian Cancer

Keywords

  • Oncolytic virus
  • Herpes simplex virus type 1
  • Immunotherapy
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Yunying Medical Technology is the lead sponsor of 7 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with advanced solid tumors 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

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 severe prior interstitial lung changes (as determined by the investigator).
  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 4.0 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. Pregnant, lactating and planning to have children within six months.
  13. Subjects who, in the judgment of the investigator, are unsuitable for participation in this trial for any reason.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    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 intraperitoneal in patients with advanced solid tumors

    Drug: Recombinant oncolytic herpes simplex virus type 1 (R130)

Interventions

  • DrugRecombinant oncolytic herpes simplex virus type 1 (R130)

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

    Also known as: Oncolytic virus

06

What researchers measure

Primary outcomes

  1. Subject incidence of adverse events

    To characterize the safety profile of R130 injection in patients with advanced solid tumors as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)

    Time frame: Up to 6 months

  2. Subject incidence of laboratory abnormalities

    Detection of liver and renal function, electrocardiogram, routine blood examination etc.

    Time frame: Up to 1 month

  3. Systemic Immune Response

    Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa,IFNγ, etc.) and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)

    Time frame: Up to 6 months

Secondary outcomes

  1. Disease Assessment for Disease Control Rate

    Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST

    Time frame: Every 10 weeks for 12 months

  2. Disease Assessment for Duration of Response

    Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST

    Time frame: Every 10 weeks for 12 months

  3. Quality of Life Assessment

    Evaluate with EORTC QLQ-C30

    Time frame: Every 6 weeks for 12 months

07

Study locations

1 of 1 sites recruiting
  • The PLA Navy Anqing Hospital
    Anqing, Anhui 246000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05886075
Lead sponsor
Shanghai Yunying Medical Technology
Collaborators
The PLA Navy Anqing Hospital
Responsible party
Sponsor
First posted
Jun 2, 2023
Start date
Mar 30, 2023
Primary completion
Mar 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Jun 2, 2023

Study contacts

Feng Pan, Ph.D
Contact
pf@jxyymedtech.com
+8613764868528

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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