Actively Recruiting
A Clinical Study of GO306 in Patients With Advanced Solid Tumors
Led by GeneSail Biotech (Shanghai) Co., Ltd. · Updated on 2025-12-19
32
Participants Needed
6
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study employs a single-arm, open-label, non-randomized, dose-escalation design to investigate the safety, tolerability, and efficacy of GO306 Recombinant Oncolytic Vaccinia Virus Injection. * Part 1: Utilizes the 3+3 design principle to evaluate the safety and tolerability of a single administration of GO306 at different dose levels. The primary goal is to determine the Maximum Tolerated Dose (MTD), providing the basis for selecting the Recommended Phase 2 Dose (RP2D). * Part 2: Evaluates the safety and tolerability of repeated intratumoral (IT) or intracavitary administrations of GO306 in patients with specific tumor types.
CONDITIONS
Official 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 treatment
- Specific tumor types include bladder urothelial carcinoma, ovarian cancer with malignant ascites, colorectal cancer with liver metastases, clear-cell renal carcinoma, triple-negative breast cancer, neuroendocrine tumors, and other advanced solid tumors
- Patients with malignant ascites from ovarian or digestive tract tumors planning intracavitary injection must have pathologically confirmed malignant ascites and recurrent Grade 2 ascites within 4 weeks after local treatment
- At least one lesion suitable for intratumoral injection measurable by RECIST 1.1 criteria
- ECOG performance status of 0 to 2
- Expected survival time of 3 months or more
- Adequate organ function including blood counts, liver, kidney, and coagulation parameters
- Willingness and ability to comply with study requirements including treatment and follow-up
You will not qualify if you...
- Pregnant or breastfeeding women
- Diagnosis of another malignancy within the past 2 years except low-risk cancers
- Unresolved adverse effects from prior antitumor therapy above grade 1 except alopecia or hyperpigmentation
- Antitumor therapy within 4 weeks before study drug use except certain drugs with longer washout periods
- Active hepatitis B or C infection, HIV, active syphilis, or clinically significant immunodeficiency
- History of active autoimmune disease requiring systemic therapy or recent immunosuppressive treatments
- Prior allogeneic tissue or organ transplant
- Severe cardiovascular or cerebrovascular disease including heart failure, low heart function, prolonged QT interval, recent major events, or uncontrolled hypertension
- Recent significant bleeding or conditions with bleeding risk
- Severe skin diseases requiring systemic treatment within 2 years
- Severe allergy or hypersensitivity reactions to drugs or biologics
- Use of anticoagulants or antiplatelet drugs that cannot be safely stopped before injection
- Use of systemic immunomodulatory drugs within 14 days before study drug
- Recent infections requiring systemic treatment or hospitalization
- Recent participation in other investigational drug trials or live vaccines
- Recent major surgery within 4 weeks or planned during the trial
- Use of certain CYP450 sensitive drugs not stopped before study drug
- Mental illness or substance abuse interfering with participation
- High treatment risk assessed by investigators
- Plans to join other trials, leave the site, or unsuitable for participation as assessed by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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