A Clinical Study of GO306 in Patients With Advanced Solid Tumors

NCT07128914 | Recruiting Phase 1

• 1 other identifier: GS-CN-GO306-202501
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

Brief Summary

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

Solid Tumor Malignancies

Keywords

GO306; Solid tumor malignancies; Oncolytic Viral Therapy

Outcome Measures

Primary Outcomes (5)

• AEs

  Adverse events (AEs) will be graded according to the CTCAE Version 5.0 published by the U.S. National Cancer Institute.

  Within 6 Months After the Last Treatment

• SAEs

  Severe Adverse events (SAEs) will be graded according to the CTCAE Version 5.0 published by the U.S. National Cancer Institute.

  Within 6 months after the last treatment.

• DLT

  The Dose-Limiting Toxicities (DLTs) assessed using the NCI CTCAE v5.0.

  Up to 21 days from the first GO306 injection.

• MTD

  The maximum tolerated dose (MTD) of GO306 will be defined based on the DLT

  Up to 21 days from the first GO306 injection.

• RP2D

  The Recommended Phase II Dose (RP2D) will be determined based on the integrated analysis of Part 1 (3+3 dose-escalation phase) results.

  Through the Part 1 of this study, an average of 4 months

Secondary Outcomes (7)

• Pharmacodynamics/immunological indicators

  In Part 1&2: Within 28 Days After the Last Dose

• Pharmacokinetics/viral shedding indicators

  Part 1&2: Within 28 Days After the Last Dose

• Immunogenicity indicators

  Part 1&2: Within 6 Months After the Last Dose

• OS

  Up to 5 years after the last treatment.

• PFS

  Up to 5 years after the last treatment.

Study Arms (1)

GO306 Treatment

EXPERIMENTAL

This is a single-arm, non-randomized study which comprises two parts: * Part 1: A 3+3 single-dose escalation phase to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicities (DLTs), and Recommended Phase II Dose (RP2D) of the investigational product. * Part 2: A multiple-dose expansion phase at the RP2D level to explore preliminary efficacy in specific tumor types.

Drug: GO306

Interventions

GO306 DRUG

Part 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.

GO306 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years old and above, regardless of gender.
• Patients with histologically or cytologically confirmed advanced malignant solid tumors, including but not limited to breast cancer, bladder urothelial cancer, colorectal cancer, renal cancer, ovarian epithelial cancer, and neuroendocrine tumors, who have no response or failure to standard treatment (including disease progression and/or intolerable side effects), or no standard treatment. Examples are as follows:
• 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.
• d. Patients with histologically or cytologically confirmed unresectable or metastatic clear-cell renal carcinoma with prior failure to, or intolerance to, Tkis and PD-1/PD-L1 inhibitors or no available standard treatment options for unresectable or metastatic clear-cell renal carcinoma.
• e. Histologically or cytologically confirmed, locally advanced or metastatic triple-negative breast cancer: failure to or intolerance to at least one previous line of standard chemotherapy, which must include a taxane (e.g., paclitaxel, docetaxel), or no standard treatment options available.
• f. For patients with neuroendocrine tumors, one of the following criteria must be met:
• (1) Patients with histologically confirmed advanced stage (inoperable locally advanced or distant metastasis) with Ki-67≥55% in G3 NET and NEC (including mixed neuroendocrine and non-neuroendocrine tumors \[at least 30% neuroendocrine carcinoma component\], excluding small cell lung cancer and Meckel cell carcinoma) : They have failed or are intolerant to at least one previous line of standard chemotherapy (EP or EC), or no standard treatment options are available.
• (2) Histologically confirmed advanced NET G3 patients (unresectable locally advanced or distant metastasis) and atypical pulmonary and mediastinal carcinoid patients: patients who had received at least second-line standard treatment failed or could not tolerate it, and the treatment regimen must include CAPTEM regimen or no available standard treatment regimen.
• g. Histologically or cytologically confirmed advanced solid tumors (other than the above, e.g., soft tissue sarcoma, etc.) : documented disease progression or intolerance during or after receiving previous standard therapy, or no standard treatment options are available.
• Patients with ovarian cancer and solid malignant tumors of the digestive tract with malignant ascites who plan intracavitary injection should meet the following requirements:
• a. Malignant ascites was pathologically diagnosed as caused by the spread of cancer cells.
• b. Grade ≥2 ascites recurred within 4 weeks after receiving at least one local treatment (including paracentesis, intraperitoneal chemotherapy, intraperitoneal venous shunt, hyperthermic intraperitoneal perfusion, etc.).
• c. Massive peritoneal effusion confirmed by computed tomography (CT) or B-ultrasound, which clinically requires local treatment for peritoneal effusion.

You may not qualify if:

• 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.
• 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.
• Presence of any of the following infections or diseases:
• a. Active hepatitis B (HbsAg positive and/or HbcAb positive with an HBV DNA test value greater than the upper limit of normal); Active hepatitis C (anti-HCV antibody positive for further HCV RNA positive).
• b. A known history of immunodeficiency virus (HIV) disease or HIV antibody positive or active syphilis.
• c. evidence of clinically significant immunodeficiency such as a primary immunodeficiency state such as severe combined immunodeficiency (SCID); Opportunistic bacterial infection.
• Have a history of active autoimmune disease requiring systemic therapy such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., or have been receiving long-term systemic steroids (prednisone \>10mg/ day or equivalent dose of the same drug) or any other form of immunosuppressive therapy within 14 days before the first use of the investigational drug. Patients with clinically stable autoimmune thyroid disease were excluded. The patients were treated with topical and inhaled corticosteroids, such as ocular, intra-articular, nasal, etc. Short-term use of glucocorticoids (not more than 3 days) for prophylaxis (e.g., to prevent contrast allergy); Physiological doses of hormone replacement therapy.
• Received allogeneic tissue or solid organ transplantation.
• A history of severe cardiovascular and cerebrovascular disease, including but not limited to:
• a. New York Heart Association (NYHA) class ≥II congestive heart failure.
• b. left ventricular ejection fraction (LVEF) \<50%.
• c. QT interval corrected with Fridericia's method (QTcF) \>470 ms or syndrome of prolonged QT interval.
• d. Acute coronary syndrome, aortic dissection, major arrhythmia, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first dose of dose.
• e. Presence of uncontrolled hypertension (systolic BP, \>150 mmHg or diastolic BP, \>100 mmHg) Subjects with a history of hypertension were allowed to participate if blood-pressure control below this criterion was achieved and maintained with antihypertensive treatment.

Sponsors & Collaborators

• GeneSail Biotech (Shanghai) Co., Ltd.: lead

Study Sites (6)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Shenzhen Third People's Hospital

Shenzhen, Guangzhou, 518112, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Shanghai General Hospital

Shanghai, Shanghai Municipality, 201620, China

RECRUITING

Central Study Contacts

Zhenrui Shi

CONTACT

+86 21 20975454-1081; shizhenrui@genesailbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm, non-randomized study which comprises two parts: * Part 1: A 3+3 single-dose escalation phase to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicities (DLTs), and Recommended Phase II Dose (RP2D) of the investigational product. * Part 2: A multiple-dose expansion phase at the RP2D level to explore preliminary efficacy in specific tumor types.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 19, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)