An Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravenous With and Without Intratumoral Oncolytic Virus Injection (RT-01) Combined With or Without Immune Checkpoint Inhibitors (Nivolumab) in the Treatment of Patients With Advanced Solid Tumors

Wuxi People's Hospital1 site in 1 country36 target enrollmentNovember 1, 2021

ConditionsAdvanced Solid Tumor

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Solid Tumor
Sponsor: Wuxi People's Hospital
Enrollment: 36
Locations: 1
Primary Endpoint: Dose Limiting Toxicities (DLT)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm, open-lable study to determine the safety, tolerability and preliminary efficacy of oncolytic virus injection (RT-01) combined with or without immune checkpoint inhibitors (Nivolumab) in the treatment of patients with advanced solid tumors.

Detailed Description

To evaluate the safety, tolerability, efficacy, immunoreactivity, immunogenicity, pharmacokinetics and virus shedding of RT-01 injection given via Intravenous with or without Intratumoral administration combined with immune checkpoint inhibitors Nivolumab in the treatment of patients with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

November 1, 2021

End Date

June 1, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wuxi People's Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged ≥ 18 years;
•Have a histopathologically or cytologically confirmed dagnosis of advanced solid tumors and no existing options are felt to provide clinical benefit;
•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 cardiovascular 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;
•Ability to provide written informed consent.

Exclusion Criteria

•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 4 weeks；
•Subjects who have participate in another interventional study while receiving study IP within 4 weeks；
•Subjects who have had major surgery ≤ 4 weeks of dosing；
•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 prior to investigational drug 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 (≤ 7 days) use of corticosteroids (e.g., allergy to contrast media) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity caused by contact allergens)；
•Subjects received live vaccines within 7 days of initiation of study treatment；
•Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia)；
•Subjects who have any active infection；

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLT)

Time Frame: Up to 28 days

Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Defined as the highest safety-tolerated dose level where at most one patient out of six experiences dose limiting toxicities (DLT) with the next higher dose level having at least 2 of 6 patients who have experienced DLT.