A Clinical Study of GO306 in Patients With Advanced Solid Tumors
ConditionSolid Tumor Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneSail Biotech (Shanghai) Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years old and above, regardless of gender.
a. Histologically or cytologically confirmed unresectable or metastatic bladder urothelial carcinoma: failure to or intolerance to prior platinum-based chemotherapy and PD-1/PD-L1 inhibitors or no available standard treatment options for unresectable or metastatic disease.
b. Patients with histologically or cytologically confirmed recurrent ovarian cancer with malignant ascites who have received at least one previous line of platinum-based chemotherapy-based therapy and no available standard treatment options, and those with germline or somatic BRCA mutations who failed or did not tolerate PARP inhibitors.
c. Histologically or cytologically confirmed unresectable or metastatic colorectal cancer with liver metastases: failure or intolerance to prior oxaliplatin, fluorouracil, and irinotecan based therapy (or PD-1/PD-L1 inhibitors if the patient is MSI-H/dMMR) or no standard treatment options are available.
Disqualifiers
Female subjects who were pregnant or lactating.
Patients who had received a diagnosis 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.
The adverse effects of previous antitumor treatment have not returned to CTCAE v5.0 grade 1, baseline or lower, or the level specified in the inclusion/exclusion criteria (except for alopecia, hyperpigmentation and other adverse events judged by the investigator as no safety risk). Subjects with chronic grade 2 toxicity were eligible after discussion with the sponsor if they were asymptomatic or adequately controlled with stable medications.
Antineoplastic therapy, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, or immunotherapy, was received within 4 weeks or five half-lived periods (whichever was less) before the first use of the investigational drug, except for the following drugs: nitrosourea or mitomycin C within 6 weeks before the first use of the investigational drug; For oral fluorouracil and small molecule targeted drugs, 2 weeks before the first use of the investigational drug or within the 5 half-lives of the drug, whichever is longer; The Chinese herbal medicine or Chinese patent medicine with anti-tumor indication was within 2 weeks before the first use of the investigational drug.
Trial design
Design model
Single group
Treatments tested in this trial
GO306
DrugPart 1: A 3+3 single-dose escalation phase: Low-dose cohort: 3.0E+07 PFU; Intratumoral or intracavitary injection of GO306; Cohort Size: 3 subjects; Dosing Schedule: Single initial administration. Medium-dose cohort: 3.0E+08 PFU; Intratumoral or intracavitary injection of GO306; Cohort Size: 3 subjects; Dosing Schedule: Single initial administration. High-dose cohort: 1.0E+09 PFU; Intratumoral or intracavitary injection of GO306; Cohort Size: 3 subjects; Dosing Schedule: Single initial administration. Part 2: A multiple-dose expansion phase at the RP2D level to explore preliminary efficacy in specific tumor type: RP2D; Intratumoral or intracavitary injection of GO306; Cohort Size: 20 subjects in specific tumor type; Dosing Schedule: QW or Q2W administration.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: GO306 TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
AEs
Adverse events (AEs) will be graded according to the CTCAE Version 5.0 published by the U.S. National Cancer Institute.
Time frame
Within 6 Months After the Last Treatment2
SAEs
Severe Adverse events (SAEs) will be graded according to the CTCAE Version 5.0 published by the U.S. National Cancer Institute.
Time frame
Within 6 months after the last treatment.3
DLT
The Dose-Limiting Toxicities (DLTs) assessed using the NCI CTCAE v5.0.
Time frame
Up to 21 days from the first GO306 injection.4
MTD
The maximum tolerated dose (MTD) of GO306 will be defined based on the DLT
Time frame
Up to 21 days from the first GO306 injection.Secondary outcomes
1
Pharmacodynamics/immunological indicators
Including but not limited to: peripheral blood T lymphocyte subsets (CD3+, CD4+, CD8+, CD4+/CD8+ ratio, CD19+, etc.), plasma cytokines (IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-17, IFN-α, IFN-γ, TNF-α, etc.)
Time frame
In Part 1&2: Within 28 Days After the Last Dose2
Pharmacokinetics/viral shedding indicators
GO306 concentration (viral genome copy number) in blood, throat swabs, urine, saliva, feces, and injection site samples at different time points after a single dose, and the concentration of GO306 expression products in serum
Time frame
Part 1&2: Within 28 Days After the Last Dose3
Immunogenicity indicators
Anti-GO306 antibodies, and antibodies against GO306 expression products.
Time frame
Part 1&2: Within 6 Months After the Last Dose4
OS
Overall Survival (OS)(Basd on the RECIST V1.1): Time interval from the date of first study drug administration to the date of death due to any cause.
Time frame
Up to 5 years after the last treatment.Sponsors and contacts
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Source ClinicalTrials.gov