A Study of Intratumoral Administration of Oncolytic Virus Injection (RT-01) in Patients With Advanced Solid Tumors

NCT05205408 | Unknown Phase 1

• 1 other identifier: LWY21076CBY1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, dose escalation, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) When Administered Via Intratumoral Injection in patients with advanced solid tumors. The primary purpose of this study is to evaluate the safety and tolerability, the secondary purpose is to evaluate the antitumor activity, immunoreactivity, immunogenicity, pharmacokinetics and virus shedding of RT-01.

Conditions

Advanced Solid Tumor

Keywords

RT-01; Oncolytic Virus; immunotherapy; Intratumoral injection

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities (DLT)

  Dose-limiting toxicity is defined as an adverse event that is considered to be drug-related and meets one of the Protocol definitions

  Up to 28 days

Secondary Outcomes (7)

• Incidence of adverse events

  Up to 6 months

• To evaluate the antitumor activity.

  Up to 2 years

• The changes of the immunoreactivity during treatment

  Up to 28 days

• To evaluate the immunogenicity of RT-01

  Up to 28 days

• To evaluate the viral shedding of RT-01

  Up to 24 Weeks

Study Arms (1)

Oncolytic Virus Injection(RT-01)

EXPERIMENTAL

Intratumoral administration of RT-01 as single agent for patients with advanced solid tumors. Dose cohorts: 1×10\^8 TCID50/mL and 7×10\^8 TCID50/ mL

Biological: Oncolytic Virus Injection(RT-01)

Interventions

Oncolytic Virus Injection(RT-01) BIOLOGICAL

Administered by intratumoral injection as single agent.

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 First Affiliated Hospital of Bengbu Medical University: lead

Study Sites (1)

First Affiliated Hospital Bengbu Medical College

Bengbu, Anhui, 233030, China

RECRUITING

Central Study Contacts

zhou huan, MD

CONTACT

13665527160; zhouhuanbest@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: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Medical Oncology

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 25, 2022
• Study Start: February 24, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)