Actively Recruiting
An Open, Single-armed, Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors
Led by Shanghai Yunying Medical Technology · Updated on 2023-07-27
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Shanghai Yunying Medical Technology
Lead Sponsor
L
Linyi People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a modified herpes simplex virus called recombinant oncolytic herpes simplex virus type 1 (R130) in patients with advanced solid tumors. This early phase 1, open, single-arm clinical trial aims to study the treatment in people with various cancers such as sarcoma, carcinoma, digestive cancer, breast cancer, lung cancer, brain cancer, melanoma, gynecologic cancer, head and neck cancer, and kidney cancer. The study focuses on patients who have not responded to standard treatments or who choose not to receive other antitumor therapies. Participants will receive injections of 1 to 2 milliliters of R130 at a concentration of 1x10^8 plaque-forming units per milliliter into their tumors or abdominal cavity every 7 to 14 days. This approach allows the virus to be delivered directly to the cancer site. The study involves only one treatment group receiving the R130 virus, and no placebo or comparison group is used. During the trial, researchers will monitor participants for adverse events and laboratory abnormalities up to 6 months and assess their immune response. Disease control and response duration will be evaluated every 10 weeks for up to 12 months, while quality of life assessments will occur every 6 weeks for the same period. Participants will undergo regular laboratory tests and clinical evaluations to track safety and treatment impact. The total study duration for each participant may extend up to one year with ongoing monitoring.
CONDITIONS
Brief Title
A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with solid tumors clearly diagnosed by histology and/or cytology.
- Failure of standard treatment or patient unwillingness to receive other antitumor therapy.
- Age 18 to 75 years.
- Subjects with ECoG score of 0-2.
- Expected survival of 3 months or more.
- Have at least one measurable lesion amenable to intratumoral or intraperitoneal drug delivery.
- Appropriate organ function with specific laboratory test requirements including ANC 64 1.5 x 10^9/L, platelets 64 80 x 10^9/L, hemoglobin 64 85 g/L, serum creatinine and BUN within 1.5 times normal, bilirubin 64 2 times normal, ALT and AST 64 2.5 times normal (up to 5 times if liver metastases), and coagulation times within 1.5 times normal.
- No absolute or relative bleeding contraindications.
- Use of reliable contraception for 180 days after last dose for those of childbearing potential; negative pregnancy test within 7 days before enrollment.
- Voluntary informed consent and good compliance.
You will not qualify if you...
- History of serious adverse reactions to immunotherapy.
- Severe or uncontrolled diseases including poorly controlled hypertension, significant heart disease, active infections, prior organ or bone marrow transplant, and severe immune deficiency.
- Proteinuria over specified limits.
- Past history of type I diabetes mellitus or HIV.
- Severe thyroid or cortisol abnormalities and autoimmune diseases requiring systemic therapy.
- Severe prior interstitial lung changes.
- Active tuberculosis with strong positive OT test.
- Active bleeding or severe coagulation problems.
- Antitumor therapy within 4 weeks prior to first dose.
- Toxicity from previous cancer therapy not recovered to grade 0 or 1.
- Active hepatitis B or C, immunodeficiency virus, or other significant infections.
- Recent major surgery with unhealed wounds.
- Pregnant, lactating, or planning pregnancy within six months.
- Investigator judgment deeming unsuitability for trial participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing throughout the study period
Participants receive injections of the oncolytic virus R130 every 7 to 14 days, administered intratumorally or intraperitoneally, to treat advanced solid tumors.
Injections every 7 to 14 days
Duration - Up to 12 months
Participants undergo disease assessments every 10 weeks and quality of life assessments every 6 weeks to monitor response and safety for up to 12 months.
Disease assessments every 10 weeks and quality of life assessments every 6 weeks
Trial Site Locations
Total: 1 location
1
Linyi Central Hospital
Linyi, Shandong, China, 276000
Actively Recruiting
Research Team
F
Feng Pan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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