A Clinical Study of GO321 in Patients With Advanced Solid Tumors
ConditionSolid Tumor Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneSail Biotech (Shanghai) Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
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.);
Disqualifiers
Female participants who were pregnant or lactating.
Presence of another malignancy within the previous 2 years, except for cancers with a low risk of metastasis and death (5-year survival rate, >90%), such as adequately treated basal-cell or squamous-cell skin cancer or carcinoma in situ of the cervix and other cancers in situ.
Adverse events from prior anti-tumor therapy have not recovered to Grade ≤ 1 per CTCAE v6.0, or to the levels specified in the inclusion/exclusion criteria (with the exception of alopecia, skin hyperpigmentation, or other toxicities deemed by the investigator to have no safety risk). Participants with chronic Grade 2 toxicity may be eligible after discussion with the sponsor, provided the toxicity is asymptomatic or adequately controlled with stable medications.
Received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product; received oral fluoropyrimidines or small-molecule targeted agents within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose; received traditional Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 2 weeks prior to the first dose; received other systemic anti-tumor therapies, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose.
Trial design
Treatments tested in this trial
- GO321
Treatment groups
21 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov