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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05961111
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Collaborator:
Linyi Central Hospital
Information provided by (Responsible Party):
Shanghai Yunying Medical Technology

Study Description
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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 advanced solid tumors.

Condition or disease Intervention/treatment Phase
Sarcoma Carcinoma Digestive Cancer Breast Cancer Lung Cancer Brain Cancer Melanoma Gynecologic Cancer Head and Neck Cancer Kidney Cancer Drug: Recombinant oncolytic herpes simplex virus type 1 (R130) Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Single-armed, Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors
Actual Study Start Date : June 24, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: R130 Treatment Group
Every 7-14 days,1-2 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)
R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11
Other Name: Oncolytic virus


Outcome Measures
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Primary Outcome Measures :
  1. Subject incidence of adverse events [ Time Frame: Up to 6 months ]
    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),such as fever, fatigue, flu like symptoms, chills, Injection site reaction,etc.

  2. Subject incidence of laboratory abnormalities [ Time Frame: Up to 1 month ]
  3. Systemic Immune Response [ Time Frame: Up to 6 months ]
    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)


Secondary Outcome Measures :
  1. Disease Assessment for Disease Control Rate [ Time Frame: Every 10 weeks for 12 months ]
    CT will be performed to evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST. DCR (proportion of patients) = with CR +PR +SD /CR + PR +SD + PD.

  2. Disease Assessment for Duration of Response [ Time Frame: Every 10 weeks for 12 months ]
    The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1

  3. Quality of Life Assessment [ Time Frame: Every 6 weeks for 12 months ]
    Comparison of patients' quality of life before and after R130 treatment as assessed by the EORTC QLQ-30 (V3.0).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with 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. No absolute or relative centasis contraindiction.
  9. Eligible patients of childbearing potential must agree to use a reliable method of contraception 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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05961111


Contacts
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Contact: Feng Pan +8613764868528 pf@jxyymedtech.com

Locations
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China, Shandong
Linyi Central Hospital Recruiting
Linyi, Shandong, China, 276000
Contact: Peiliang Zhang    +86 13954939557    Zpl@souhu.com   
Sponsors and Collaborators
Shanghai Yunying Medical Technology
Linyi Central Hospital
More Information
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Responsible Party: Shanghai Yunying Medical Technology
ClinicalTrials.gov Identifier: NCT05961111    
Other Study ID Numbers: LYCH-R130
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Yunying Medical Technology:
Oncolytic virus
Herpes simplex virus type 1
Additional relevant MeSH terms:
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Kidney Neoplasms
Brain Neoplasms
Neoplasms
Neoplasms by Site
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases