Actively Recruiting
A Phase I Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of GO306 Recombinant Oncolytic Vaccinia Virus Injection in Patients With Advanced Refractory Solid Tumors
Led by GeneSail Biotech (Shanghai) Co., Ltd. · Updated on 2025-12-19
32
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and preliminary effectiveness of GO306 Recombinant Oncolytic Vaccinia Virus Injection in patients with advanced solid tumors who have not responded to standard treatments. This open-label, non-randomized trial uses a dose-escalation design to explore the best dose and safety profile. The trial has two parts: first to find the maximum tolerated dose and then to evaluate repeated doses in specific tumor types. The study involves two phases: Part 1 uses a 3+3 design with single intratumoral or intracavitary injections of GO306 at low, medium, and high doses to determine the recommended dose for further study. Part 2 involves multiple doses of GO306 given weekly or every two weeks at the recommended dose to evaluate safety and explore preliminary effectiveness in selected tumor types. Participants will receive treatment injections and undergo monitoring for side effects, pharmacokinetics, viral shedding, and immune response. Researchers will assess adverse events, dose-limiting toxicities, and treatment responses using imaging. Follow-up evaluations include laboratory tests and immunological assessments. Study participation may last months, with some outcomes monitored up to five years after treatment.
CONDITIONS
Brief Title
A Clinical Study of GO306 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically or cytologically confirmed advanced malignant solid tumors unresponsive or intolerant to standard treatments, including specific cancer types such as breast, bladder urothelial, colorectal, renal, ovarian, neuroendocrine tumors, and others
- Patients with malignant ascites from ovarian or digestive tract cancers planning intracavitary injection must meet specific clinical criteria
- At least one tumor lesion evaluable by imaging and suitable for intratumoral injection
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
- Expected survival time of at least 3 months
- Adequate organ function based on laboratory tests
- Willingness and ability to comply with study requirements including contraception and follow-up
You will not qualify if you...
- Pregnant or breastfeeding females
- Diagnosis of another malignancy within the past 2 years except low-risk cancers
- Unresolved side effects from prior cancer treatments above specified severity
- Recent antitumor therapy within defined time frames before study drug administration
- Active hepatitis B or C, HIV, syphilis, or significant immunodeficiency
- History of autoimmune disease requiring systemic therapy or recent immunosuppressive treatment
- History of allogeneic tissue or solid organ transplantation
- Severe cardiovascular or cerebrovascular disease or uncontrolled hypertension
- Recent significant bleeding events or conditions increasing bleeding risk
- Severe skin diseases requiring systemic treatment within 2 years
- Severe allergy or hypersensitivity to drugs or biological products
- Use of anticoagulants or certain antiplatelet drugs that cannot be safely interrupted before injection
- Use of systemic immunomodulatory drugs within 14 days before study drug
- Serious infections requiring recent systemic anti-infective treatment
- Recent participation in other investigational drug studies or live vaccinations
- Recent major surgery or planned major surgery during the trial
- Use of certain CYP450-metabolized drugs that cannot be stopped
- Mental illness or substance abuse interfering with trial participation
- High treatment risk as assessed by investigators
- Plans to participate in another clinical trial during this trial or inability to continue participation as judged by investigators
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 - Part 1: Single administration; Part 2: Multiple doses weekly or biweekly
Participants receive GO306 through intratumoral or intracavitary injections. Part 1 involves a single dose at one of three escalating dose levels to determine safety and maximum tolerated dose. Part 2 involves multiple doses of GO306 administered weekly or every two weeks at the recommended dose to evaluate safety and preliminary efficacy.
1 visit for single-dose administration in Part 1; Weekly or biweekly visits during multiple-dose treatment in Part 2
Duration - Up to 6 months after the last treatment for safety and immunogenicity; up to 5 years for long-term survival outcomes
Participants are monitored for safety, pharmacokinetics, immunogenicity, and efficacy outcomes after the last GO306 treatment.
Regular visits for assessments during follow-up period
Trial Site Locations
Total: 6 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
3
Shenzhen Third People's Hospital
Shenzhen, Guangzhou, China, 518112
Actively Recruiting
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
5
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
6
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 201620
Actively Recruiting
Research Team
Z
Zhenrui Shi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here