A Study of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor in Patients With Advanced Solid Tumors

NCT05228119 | Unknown Phase 1

• 1 other identifier: LWY21076CXY
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in combination with PD-1 inhibitor (Nivolumab) in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01 in combination with PD-1 inhibitor.

Conditions

Advanced Solid Tumor

Keywords

RT-01; Oncolytic Virus; PD-1 Inhibitor; immunotherapy; immune Checkpoint Inhibitors; Intravenous Injection; Intratumoral injection

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 RT-01 in blood

  Up to 22 Weeks

• The rate of subjects with viral shedding of RT-01

  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(RT-01)

EXPERIMENTAL

RT-01 will be administered either intravenously or with a combination of intravenously and intratumorally on day 1. Nivolumab will be administered intravenously every 3 weeks starting on day 5.

Biological: Oncolytic Virus Injection(RT-01)

Interventions

Oncolytic Virus Injection(RT-01) BIOLOGICAL

Intravenous injection with or without intratumoral injection of a single dose of RT-01 and intravenous infusion of Nivolumab

Oncolytic Virus Injection(RT-01)

Eligibility Criteria

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

You may qualify if:

• Male or female aged ≥ 18 years;
• Subjects must have histologically or cytologically confirmed diagnosis of advanced solid tumor(s) who have failed in standard therapy (disease progression or intolerance) and no effective treatment, or have no standard therapy, or have failed to obtain standard treatment due to objective conditions ;
• Subjects have At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
• ECOG score of 0 \~ 2;
• Adequate bone marrow, hepatic and renal and coagulation function;
• Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
• Voluntarily participated in this study, signed the informed

You may not qualify if:

• Subjects with known brain metastasis and/or clinically history tumor brain of metastasis；
• Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 2 weeks before RT-01 administration；
• Subjects who have participate in another interventional study within 4 weeks before RT-01 administration；
• Subjects who have had major surgery within 4 weeks before RT-01 administration；
• Patients in any condition requiring systemic treatment with corticosteroids (prednisone \> 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days before RT-01 administration, but currently or previously treated with any of the following steroid regimens, were included: Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; Prophylactic short-term use of corticosteroids；
• Subjects who have participate in another oncolytic virus study within 8 weeks before RT-01 administration；
• Subjects received live vaccines within 7 days before RT-01 administration；
• Subjects received Antiviral drugs within 2 weeks, long-acting interferon within 4 weeks before RT-01 administration；
• Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia);
• Subjects who have uncontrolled active infection;
• Subjects with known positive history of human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS);
• Subjects who have active hepatitis;
• Subjects who have serious cardiovascular system disorders history;
• Subjects with active autoimmune diseases or history of autoimmune diseases that may relapse;
• Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

RECRUITING

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: January 3, 2022
• First Posted: February 8, 2022
• Study Start: January 4, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)