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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 (according to RECIST 1.1 criteria) that is amenable to intratumoral or intraperitoneal drug delivery.

• 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.

• No absolute or relative centasis contraindiction.

• 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.

⁃ Subjects voluntarily sign an informed consent form and are in good compliance.

Locations
Other Locations
China
Xuzhou Second People's Hospital
RECRUITING
Shanghai
Contact Information
Primary
Feng Pan, MD
pf@jxyymedtech.com
+8613764868528
Time Frame
Start Date: 2023-03-02
Estimated Completion Date: 2026-03-02
Participants
Target number of participants: 20
Treatments
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
Sponsors
Collaborators: The Affiliated Hospital of Xuzhou Medical University
Leads: Shanghai Yunying Medical Technology

This content was sourced from clinicaltrials.gov