A Clinical Study of GO321 in Patients With Advanced Solid Tumors (NCT07748117) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Study of GO321 in Patients With Advanced Solid Tumors
China21 participantsStarted 2026-08-15
Plain-language summary
The goal of this clinical trial is to learn about the safety and tolerability of GO321 recombinant oncolytic virus injection, and if GO321 recombinant oncolytic virus injection works to treat advanced solid tumors in adults whose cancers have progressed after standard-of-care therapy. It will also learn about the pharmacokinetic features, viral shedding, immunogenicity of GO321, immune markers, and genomic and proteomic changes in patients. The main questions it aims to answer are: What safety issues and tolerability limitations do participants experience when receiving GO321 via intratumoral or intracavitary injection? Does GO321 have preliminary anti-tumor efficacy against advanced solid tumors resistant to standard treatment? What changes take place in viral distribution, viral shedding, immunity, blood immune markers, tumor or blood genomics and proteomics after GO321 administration? Researchers will assess different doses and dosing schedules of GO321 given by intratumoral or intracavitary injection across two study phases to find a suitable administration dose and regimen and verify the study endpoints.
Participants will:
Receive either a single injection of GO321 at different dose levels (in Part 1) or repeated GO321 injections at the recommended Phase 2 dose (in Part 2) by intratumoral or intracavitary routes; Complete scheduled hospital visits to undergo laboratory tests, imaging examinations and biological sample collection; Have their safety indicators, anti-tumor response, viral parameters, immune indicators and molecular profiles tracked throughout the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years old and above, regardless of gender.
* Histologically or cytologically confirmed advanced malignant solid tumors that are refractory to or have failed standard therapy (including disease progression and/or intolerance to toxicity), or for which no standard therapy is available.
* For patients with malignant ascites secondary to malignant tumors (e.g., ovarian cancer, gastrointestinal solid malignancies) who are planned to receive intracavitary injection, the following criteria must be met:
* a. Malignant ascites is determined by the investigator to be caused by cancer cell dissemination, and not complicated by ascites due to other etiologies;
* b. Recurrence of ≥ Grade 2 ascites within 4 weeks after at least one prior local therapy (including paracentesis, intraperitoneal chemotherapy, peritoneovenous shunt, hyperthermic intraperitoneal chemotherapy, etc.);
* c. Large-volume peritoneal effusion confirmed by computed tomography (CT) or ultrasound, with a clinical indication for local therapeutic intervention targeting the ascites.
* Patients scheduled for intratumoral injection must meet the following requirements: At least one evaluable lesion confirmed by local imaging per RECIST v1.1 that is amenable to intratumoral injection. A lesion suitable for intratumoral injection (with or without CT/ultrasound guidance) is defined as a palpable mass or a mass visible by CT/ultrasound that can be injected under CT/ultrasound guidance, locate…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial of GO321 that hasn't started enrolling yet, can you help me understand what that means for how much is currently known about its safety and effectiveness in people?
2The study is measuring dose-limiting toxicities and recommending a dose — which tells me they're still figuring out the right amount to give — so what kinds of side effects or serious adverse events might be a concern based on how GO321 works?
3Because this trial isn't recruiting yet, is there a realistic timeline for when it might open, and would waiting for it potentially affect my other treatment options in the meantime?
4For someone with my specific type of advanced solid tumor, would you consider a standard treatment approach first, or is there a reason this early-phase study might be worth discussing as an option for me?
5What would my participation actually look like day-to-day — things like how often I'd need to come in for monitoring — and is that something that would be realistic given my current situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AEs
Timeframe: Up to 6 months after the last GO321 administration
2
SAEs
Timeframe: Up to 6 months after the last GO321 administration.
3
DLT
Timeframe: within 28 days after the first GO321 administration.
4
RD
Timeframe: Through study of Part 1 completion, an average of 9 months.