Suspended

A Single-Arm, Open-Label, Dose Escalation Study to Evaluate Safety and Efficacy of Intratumoral Injection of Oncolytic Virus Injection (RT-01) in Patients With Advanced Solid Tumors

What is being tested

Oncolytic Virus Injection(RT-01)

Biological

Who is being recruted

Over 18 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: February 2022

See protocol details

Summary

Principal SponsorThe First Affiliated Hospital of Bengbu Medical University

Study Contactzhou huan, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 24, 2022

Actual date on which the first participant was enrolled.

This is an investigator initiated , single-arm, open-label, dose escalation clinical pharmacology study of RT-01 as a single agent given via Intratumoral injection in patients with advanced solid tumors. The study is a single agent dose escalation which will use an accelerated and "3+3" design to evaluate escalating doses of RT-01. Total enrollment will depend on the toxicities and/or activity observed, with approximately 6-12 evaluable participants enrolled. A Dose-Limiting Toxicity (DLT) observation period of 4 weeks was established before the entry of the first patient at the next dose level.

Official TitleA Single-Arm, Open-Label, Dose Escalation Study to Evaluate Safety and Efficacy of Intratumoral Injection of Oncolytic Virus Injection (RT-01) in Patients With Advanced Solid Tumors

NCT05205408

Principal SponsorThe First Affiliated Hospital of Bengbu Medical University

Study Contactzhou huan, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate

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;

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16 exclusion criteria prevent from participating

Subjects who have uncontrolled active infection;

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;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

First Affiliated Hospital Bengbu Medical College

Bengbu, ChinaOpen First Affiliated Hospital Bengbu Medical College in Google Maps

SuspendedOne Study Center