RecruitingPhase 1NCT06508307

A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors

A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of the Virus, Pharmacodynamics, Immunogenicity, and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patient With Advanced Solid Tumors.


Sponsor

GONGCHU Biotechnology Co., Ltd

Enrollment

21 participants

Start Date

Apr 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The present trial is an open, single-arm phase I clinical study aimed at assessing the safety, tolerability, viral distribution and shedding patterns, pharmacodynamics, immunogenicity, and antitumor efficacy of GC001 oncolytic virus injection in patients with advanced solid tumors following a single administration.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I study testing a new cancer treatment — a virus called GC001 that is engineered to infect and kill cancer cells (an oncolytic virus) — by injecting it directly into tumors. It is being tested in patients with advanced solid tumors that have not responded to other treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with an advanced solid tumor (such as colorectal, lung, ovarian, or cervical cancer) confirmed by biopsy - Your cancer has progressed or you have not responded to standard treatments - You are in adequate overall health and your major organs are functioning well **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have a serious autoimmune disease - You are on immunosuppressive medications - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALA Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors

The maximum number of lesions that each participant is allowed to inject at one time is two.


Locations(1)

Henan Cancer Hospital

Zhengzhou, Henan, China

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NCT06508307


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