A Study of Oncolytic Virus Injection (RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer

NCT05205421 | Unknown Phase 1

• 1 other identifier: LWY21076CBY2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer. 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.

Conditions

Advanced Solid Tumor

Keywords

RT-01; Oncolytic Virus; PD-L1 Inhibitor; immunotherapy; Intravenous Injection; Small-cell lung cancer

Outcome Measures

Primary Outcomes (7)

• Incidence of adverse events

  Graded according to the NCI CTCAE version 5.0.

  Up to 6 months

• To evaluate the antitumor activity

  To assessed per RECIST and iRECIST

  Up to 2 years

• The changes of the immunoreactivity during treatment.

  Peripheral blood T lymphocyte subtype

  Up to 28 days

• To evaluate the immunogenicity of RT-01

  Antiviral antibody

  Up to 28 days

• To evaluate the viral shedding of RT-01

  Viral RNA

  Up to 24 Weeks

• The Cmax of Viral RNA

  The maximum RNA peak concentration

  Up to 24 Weeks

• The Tmax of Viral RNA

  The time of maximum RNA peak concentration

  Up to 24 Weeks

Study Arms (1)

Oncolytic Virus Injection(RT-01)

EXPERIMENTAL

RT-01 will be administered by intravenously;

Biological: Oncolytic Virus Injection(RT-01)

Interventions

Oncolytic Virus Injection(RT-01) BIOLOGICAL

Intravenous injection a single dose of RT-01

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 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;
• Subjects in other conditions that are considered unsuitable for this study by 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

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: January 18, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)