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A Clinical Study of Intratumoral Administration of RT-01 in Patients With Advanced Solid Tumors

NCT05136937 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-01-31

No results posted yet for this study

Summary

This is an open-label, dose escalation study of the safety and tolerability of oncolytic virus injection(RT-01) when administered via intratumoral injection in patients with advanced solid tumors. The purpose of this study is to assess the safety and tolerability of RT-01 and to determine the recommended phase 2 dose (RP2D) for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of RT-01.

Conditions

Interventions

BIOLOGICAL

Oncolytic Virus Injection(RT-01)

Administered by intratumoral injection for 3 dose cohorts: 1×10\^7 TCID50/mL, 1×10\^8 TCID50/mL and 7×10\^8 TCID50/mL

Sponsors & Collaborators

  • Wuxi People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-06-01
Completion
2023-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05136937 on ClinicalTrials.gov