Health TrialsbyHealthPanel

Platform Study of VSV-Based Recombinant Oncolytic Viruses for the Treatment of Advanced Malignant Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

To evaluate the safety and tolerability of combined administration of VSV injection solutions carrying different targets via multiple routes for treating advanced malignant solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the informed consent form, understand this study, and agree to comply with the protocol and complete all trial procedures

Be at least 18 years of age at the time of signing the ICF, with no gender restrictions.

Patients with advanced solid tumors confirmed by histopathological/cytological examination of primary and/or metastatic lesions.

Patients who have failed standard therapy, lack a standard last-line treatment option, or are medically ineligible for standard therapy.

Disqualifiers

Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, and subjects with malignancies within the scope of the indication.

Lesions intended for injection with a maximum diameter >100 mm；

Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks；

Subjects scheduled for or who have previously undergone tissue/organ transplantation；

Trial design

Design model

Parallel

Treatments tested in this trial

  • VSV injection

    Biological/Vaccine

    Administer twice every two weeks.

Treatment groups

27 Participants
are divided into 3 treatment groups
Group A: VM7V02Experimental treatment 1 intervention
Group B: VM8V02Experimental treatment 1 intervention
Group C: VM8V01Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Dose-Limiting Toxicities (DLTs)

Incidence and characteristics of DLTs graded according to NCI CTCAE v5.0. The DLT observation period is 21 days post-administration.

Time frame
Within 21 days after administration
2

Incidence of Adverse Events (AEs)

Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.

Time frame
From signing ICF until 24 months after the last infusion.

Secondary outcomes

1

Objective Response Rate (ORR)

Overall response rate assessed per RECIST 1.1

Time frame
Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
2

Duration of Response (DOR)

The time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death from any cause.

Time frame
Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
3

Progression-Free Survival (PFS)

The time from the first dose of study drug until the first documentation of objective tumor progression or death from any cause.

Time frame
Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
4

Overall Survival (OS)

The time from the first dose of study drug to death from any cause.

Time frame
Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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