Study on the Treatment of Advanced Malignant Solid Tumor With Revottack and PD-1 Inhibitor

NCT05644509 | Unknown Phase 1

• 1 other identifier: LWY22078CXY
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a one arm, open clinical pharmacological exploration study initiated by researchers to evaluate the safety and effectiveness of vesicular stomatitis oncolytic virus injection (Revottack) combined with PD-1 inhibitor in patients with advanced malignant solid tumors. The purpose of this study is to evaluate the safety, tolerability, anti-tumor activity, immunogenicity, immune response, pharmacokinetic (PK) characteristics and shedding characteristics of Revottack injection combined with PD-1 inhibitor in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Keywords

Oncolytic Virus; Revottack; PD-1(Toripalimab); Intravenous Injection; immunotherapy; immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (8)

• Incidence of adverse events

  Graded according to the NCI CTCAE version 5.0.

  Up to 6 months

• Objective response rate

  Assess the proportion of patients who achieved complete or partial response

  Up to 2 years

• Disease control rate

  Assess the proportion of patients who achieved complete or partial or stable response

  Up to 2 years

• The changes from baseline of lymphocyte counts

  The changes from baseline of Peripheral blood lymphocyte subtypes counts

  Up to 28 days

• The concentration of antiviral antibody

  The concentration of antiviral antibody of Revottack in blood

  Up to 22 Weeks

• The rate of subjects with viral shedding of Revottack

  The rate of subjects with viral RNA in the secretion

  Up to 22 Weeks

• The Tmax of Viral RNA in blood

  Time to peak viral RNA concentration

  Up to 22 Weeks

• The Cmax of Viral RNA in blood

  The peak viral RNA concentration

  Up to 22 Weeks

Study Arms (1)

Oncolytic Virus Injection（Revottack）+PD-1

EXPERIMENTAL

In the first three cycles, the subjects were administered on the first day and the sixth day of each cycle respectively; At the beginning of the fourth cycle, the subjects were administered on the sixth day of each cycle, 14 days a cycle. PD-1 inhibitor(Toripalimab) Intravenous infusion, once every 2 weeks from the 6th day.

Biological: Oncolytic Virus Injection（Revottack）+PD-1

Interventions

Oncolytic Virus Injection（Revottack）+PD-1 BIOLOGICAL

Intravenous injection of Revottack injection combined with PD-1(Toripalimab） inhibitor

Oncolytic Virus Injection（Revottack）+PD-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age at the time of signing the informed consent is ≥ 18 years old, regardless of gender;
• Patients with advanced malignant solid tumor confirmed by histology or cytology; Failure in standard treatment (disease progression or intolerable treatment after treatment) and no effective treatment means, or no standard treatment scheme, or inability to obtain standard treatment due to objective conditions.
• According to RECIST 1.1, there is at least one assessable tumor focus with the longest diameter ≥ 10mm (if it is a malignant lymph node, the short diameter ≥ 15mm is required);
• ECOG physical strength score 0-2;
• Full organ function:
• Blood system (no blood transfusion or hematopoietic stimulator treatment within 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelet (PLT) ≥ 75 × 109/L Hemoglobin (Hb) ≥ 80g/L Lymphocyte absolute value (LYM) ≥ 0.8 × 109/L liver function Total bilirubin (TBIL) ≤ 1.5 × ULN Alanine aminotransferase (ALT) ≤ 3 × ULN (Patients with liver metastasis or liver cancer: ≤ 5 × ULN ) Aspartate aminotransferase (AST) ≤ 3 × ULN (Patients with liver metastasis or liver cancer: ≤ 5 × ULN) renal function Creatinine clearance rate (Ccr) \> 50ml/min/1.73m2 (calculated according to Cockcroft Gault formula) Coagulation function test Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN
• Eligible patients (male and female) with fertility must agree to work in Revottack Use reliable contraceptive methods (hormone or barrier method or abstinence) within 6 months after injection; The blood pregnancy test of female patients of childbearing age must be negative within 7 days before enrollment;
• Subjects must give informed consent to the study before the study, and voluntarily sign a written informed consent form.

You may not qualify if:

• Patients with active CNS metastasis and/or carcinomatous meningitis are known or found during screening. However, the following subjects are allowed to be included in the group: ① Patients with asymptomatic brain metastasis (that is, patients without progressive central nervous system symptoms caused by brain metastasis do not need to use corticosteroids) can participate. ② Subjects who had been treated and had stable brain metastases for at least 2 months had no evidence of new or expanded brain metastases.
• He received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatments within 2 weeks before the first use of the study drug;
• Participated in other unlisted clinical studies within 4 weeks before the first use of the study drug;
• Major organ surgery (excluding puncture biopsy) or significant trauma occurred within 4 weeks before the first use of the study drug, or major elective surgery required during the study period.
• Patients who received systemic corticosteroids (prednisone\>10mg/day or equivalent dose of the same drug) or other immunosuppressants within 14 days before the first use of the study drug; The following cases are excluded: local, eye, intra articular and intranasal corticosteroids are used for treatment; Short term use of corticosteroids for prevention and treatment;
• Have received other oncolytic virus treatment within 8 weeks before the first use of the study drug;
• Any vaccine was inoculated within 7 days before the first use of the study drug;
• Antiviral drugs were used within 2 weeks before the first use of the study drug, and long-acting interferon was used within 4 weeks;
• The adverse reaction of previous anti-tumor treatment has not recovered to ≤ 1 level (except for the toxicity judged by the researcher as no safety risk, such as alopecia, hypothyroidism stabilized by hormone replacement therapy, etc.);
• Uncontrolled active infection exists, which may seriously affect the efficacy and safety evaluation as judged by the researcher;
• Have a history of immunodeficiency, including HIV antibody test positive;
• Active hepatitis B (HBsAg positive and HBV DNA\>the lower detection limit of the research center), or hepatitis C virus infection (anti HCV positive or HCV RNA positive), or syphilis infection;
• Cardiovascular and cerebrovascular diseases shall conform to any of the following:
• Poor control of hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
• Cardiac function ≥ Grade 2 congestive heart failure (NYHA classification);

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

Location

Central Study Contacts

Han Zhengxiang, MD

CONTACT

18052268612; cnhzxyq@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)