VSV-02 Compassionate Use in Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xinxiang Medical College
About this trial
This is a clinical study for patients with advanced solid tumors who have limited or no effective treatment options available. The study aims to evaluate a new investigational drug called VSV-02 Injection, which is developed by Shanghai Rongrui Pharmaceutical Technology Co., Ltd.
The main purpose of this open-label, single-arm study is to assess the preliminary effectiveness and safety of VSV-02 when it is given through two routes: directly into a vein (intravenously) and by injection directly into the tumor (intratumorally). Patients will receive the treatment on the first day of each 3-week cycle, for up to 6 cycles.
The study will follow a dose-escalation design to find a suitable dose. Treatment may be stopped if the disease progresses, if side effects become intolerable, or if the patient chooses to withdraw, among other reasons. Researchers will closely monitor patients to see if VSV-02 can help control the cancer and to record any side effects that may occur.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
VSV-02 Injection
Biological/VaccineVSV-02 Injection is an oncolytic virus vaccine based on an attenuated Vesicular Stomatitis Virus (VSV) that is engineered to encode a CD3/PD-L1 bispecific antibody. It is supplied as a sterile solution by Shanghai Rongrui Pharmaceutical Technology Co., Ltd., with a specification of 1 mL per vial and a viral titer of 3.0×10\^10 PFU/mL. The investigational product is administered via two routes: intratumoral (IT) injection followed by intravenous (IV) infusion on Day 1 (D1) of each 21-day treatment cycle. Patients may receive up to 6 cycles of treatment. In this dose-escalation study, participants are enrolled into predefined dose cohorts. The starting dose for the first cohort is 6×10\^10 PFU via intratumoral injection and 6×10\^11 PFU via intravenous infusion.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: VSV-02 Dose Escalation GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as assessed by the investigator.
Time frame
From enrollment until the first occurrence of disease progression or the end of treatment, up to 24 months.2
Disease Control Rate (DCR)
DCR is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (lasting for at least 6 weeks) per RECIST 1.1.
Time frame
From enrollment until the first occurrence of disease progression or the end of treatment, up to 24 months.3
Duration of Response (DoR)
DoR is defined as the time from the first documentation of CR or PR to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first, as per RECIST 1.1.
Time frame
From the first objective response (CR or PR) until disease progression or death from any cause, assessed up to 36 months.4
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documentation of progressive disease (PD) as per RECIST 1.1 or death from any cause, whichever occurs first.
Time frame
From enrollment until the first occurrence of disease progression or death from any cause, assessed up to 36 months.Secondary outcomes
1
Incidence of Adverse Events (AEs)
The incidence and severity of AEs will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Time frame
From first dose of study drug until 30 days after the last dose, up to 7 months.Sponsors and contacts
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Source ClinicalTrials.gov