Actively Recruiting
A Phase I Study Evaluating Safety, Viral Distribution, Pharmacodynamics, Immunogenicity, and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patients With Advanced Solid Tumors
Led by GONGCHU Biotechnology Co., Ltd · Updated on 2025-08-21
21
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an open, single-arm Phase I clinical trial to evaluate the safety, tolerability, viral distribution, shedding patterns, pharmacodynamics, immunogenicity, and initial antitumor effects of the GC001 oncolytic vaccinia virus injection in patients with advanced solid tumors. The study aims to identify dose-limiting toxicities, maximum tolerated dose, or maximum administered dose of the treatment in this population. This trial includes patients with various advanced solid tumors for which standard treatments are ineffective or unavailable. The study involves a dose escalation design with up to six dose groups ranging from 3 x 10^6 to 1 x 10^9 plaque-forming units (PFU). Each participant receives a single intratumoral injection of GC001, up to 4 mL based on lesion size, targeting up to two measurable extracranial lesions. A Safety Monitoring Committee oversees dose escalation decisions based on safety, tolerability, and preliminary efficacy data. The study carefully monitors viral biodistribution, shedding, pharmacodynamics, and immune responses alongside antitumor activity. Participants will be observed closely for 28 days post-injection to assess safety and dose-limiting toxicities. Follow-up includes evaluations of tumor response, duration of response, and progression-free survival for up to two years. Assessments include imaging scans, viral monitoring, and immunologic tests. The study also includes ongoing safety monitoring, with adjustments to dosing, administration schedules, and biospecimen collection times as needed. Total participation duration varies based on individual follow-up requirements.
CONDITIONS
Brief 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 and consent to the trial procedures and potential risks by signing the informed consent form
- Male or female patients aged 18 to 75 years
- Diagnosed with advanced solid tumors confirmed by histology or cytology, including colorectal, lung, ovarian, cervical cancer, etc., with no effective standard treatment or disease progression after treatment
- Have at least one measurable extracranial lesion suitable for injection as confirmed by CT or MRI within 4 weeks prior to consent
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1
- Expected survival time of at least 3 months
- Meet required organ function and bone marrow reserve criteria within 7 days before first treatment dose
- Able to communicate effectively and comply with study requirements
You will not qualify if you...
- History of other malignancies within 5 years, except low-risk cancers like treated basal or squamous cell skin cancer and carcinoma in situ
- Positive pregnancy test or lactating females of childbearing age
- Allergies to similar products or excipients or multiple drug allergies
- Severe reactions to prior smallpox vaccination
- Previous treatment with lysosomal virus, stem cell, or gene therapy products
- Use of other investigational drugs or participation in other drug trials within 28 days before first dose
- Antitumor therapy including chemotherapy, radiation, immunotherapy, or certain targeted agents within specified timeframes before first dose
- Recent surgery or interventional therapy with unhealed wounds within 28 days before first dose
- Use of systemic corticosteroids or immunosuppressive medications within 28 days before first dose, with certain exceptions
- Clinically symptomatic or poorly controlled CNS metastases
- Significant fluid accumulation like ascites or pleural effusions
- Severe cardiovascular disease or uncontrolled hypertension
- Recent serious bleeding events or bleeding risks
- Unrecovered adverse effects from prior cancer therapies
- Active infections needing antibiotics
- Active or high-risk autoimmune diseases, with some exceptions
- History of exfoliative skin conditions requiring systemic treatment
- HIV positive or active hepatitis B or C infections with exceptions
- Refusal to use adequate contraception during and after the study
- Psychiatric disorders affecting trial adherence
- Tumors requiring other antitumor therapies besides GC001
- Tumors in locations unsuitable for injection or high risk for adverse events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days from GC001 injection
Participants receive a single intratumoral injection of the GC001 oncolytic vaccinia virus in up to two lesions. The dose will be escalated across groups to evaluate safety and tolerability.
Visits during the 28-day dose-limiting toxicity observation period
Duration - Up to 2 years from GC001 injection
Participants are monitored for up to 2 years after treatment for anti-tumor activity, viral distribution, shedding, pharmacodynamics, and immunogenicity.
Regular visits for assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
M
Mo guoyu
L
luo suxia, Professor
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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