Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma

ConditionSarcoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorCNBG-Virogin Biotech (Shanghai) Ltd.

About this trial

This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.

Age 18 to 75 years old (inclusive), gender is not limited.

Patients with advanced bone and soft tissue sarcoma confirmed by histopathological or cytology, who are unresectable by surgery and have failed at least one standard treatment (among them, patients with Ewing sarcoma need to be patients without standard treatment).

According to RECIST 1.1, it is determined that at least one CT examination shows measurable and meets the volume requirement for the first injection, superficial lesions are preferred, and tumor lesions that can be injected under ultrasound guidance can also be selected (the injected lesions are preferably major tumor burden lesions), and the longest diameter of the injected lesion at baseline (short diameter for lymph node lesions) > 1.5cm.

Disqualifiers

Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of study drugs, among which oral fluorouracils and small molecule targeted drugs are the first use of study drugs. Within the first 2 weeks or the 5 half-lives of the drug (whichever is longer).

Have received other unmarketed clinical trial treatments within 4 weeks before using the study drug for the first time.

Have undergone major organ surgery (excluding puncture biopsy) or experienced significant trauma within 4 weeks before taking the study drug for the first time.

Patients who have received systemic corticosteroids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressants within 14 days before the first use of study drugs; Exceptions are the following: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids (≤10 mg prednisone equivalent) for prophylactic treatment (e.g., prevention of contrast media allergy).

Trial design

Design model

Single group

Treatments tested in this trial

Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)
Drug
VG161:1.0×10\^8PFU/day, intratumoral injection administration for 3 consecutive days, 28 days as a cycle

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Experimental: Single ArmExperimental treatment 1 intervention

Trial outcomes