Actively Recruiting
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors
Led by GONGCHU Biotechnology Co., Ltd · Updated on 2025-08-21
21
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and provide signed informed consent before any procedures
- Be male or female aged between 18 and 75 years
- Have advanced solid tumors confirmed by tissue diagnosis, with no effective standard treatment available
- Have at least one measurable extracranial lesion suitable for injection within 4 weeks before consent
- Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Expected survival of at least 3 months
- Meet specific organ function requirements within 7 days before first dose including blood counts, coagulation, liver, kidney, and heart function
- Able to communicate with the investigator and follow study requirements
You will not qualify if you...
- Diagnosis of another cancer within 5 years except certain low-risk skin or cervical cancers
- Positive pregnancy test or breastfeeding in females of childbearing age
- Allergies to similar products or excipients (two or more drug allergies)
- Severe reactions to prior smallpox vaccination
- Previous treatment with lysosomal virus, stem cell, or gene therapy products
- Participation in other drug trials or use of investigational drugs within 28 days prior to first dose
- Antitumor therapies including chemotherapy, radiation, immunotherapy within 28 days before first dose
- Use of certain targeted agents or herbal antitumor medicines within specified timeframes
- Recent surgery or unhealed wounds within 28 days before first dose
- Use of systemic corticosteroids or immunosuppressants within 28 days before first dose, with some exceptions
- Clinically significant or uncontrolled brain metastases
- Significant effusions or ascites
- History of severe cardiovascular disease or uncontrolled hypertension
- Recent severe bleeding or conditions increasing bleeding risk
- Unrecovered adverse effects from prior cancer therapies
- Active infections or severe uncontrolled diseases
- Autoimmune diseases with risk of recurrence, with exceptions for stabilized diabetes or hypothyroidism
- History of exfoliative skin conditions requiring systemic therapy
- Positive for HIV antibodies
- Active hepatitis B or C infections, with some exceptions
- Refusal to use adequate contraception during and after study
- Psychiatric disorders impacting study adherence
- Need for other antitumor therapies besides GC001
- Tumors in risky locations unsuitable for injection or study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
M
Mo guoyu
CONTACT
L
luo suxia, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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