NCT07128914

A Clinical Study of GO306 in Patients With Advanced Solid Tumors

A Phase I Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of GO306 Recombinant Oncolytic Vaccinia Virus Injection in Patients With Advanced Refractory Solid Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: GeneSail Biotech (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The study has two parts. * Part 1 is a single-dose escalation phase. * The Main Objectives of part 1 is to evaluate the safety and tolerability of single intratumoral injection/intracavitary administration of GO306 at different dose levels in patients with advanced solid tumors who failed to respond to standard treatment, and explore the maximum tolerated dose (MTD), so as to provide a basis for the recommended dose in the second stage. * The secondary objectives of Part 1 is 1) To evaluate the pharmacokinetics (PK) and viral shedding of GO306 after single intratumoral injection/intracavitary administration; 2) evaluate the preliminary efficacy of a single dose of GO306; 3) To monitor the changes of immunological parameters related to GO306 pharmacodynamics. * The exploratory objectives of Part 1 is to correlation between PD-L1 expression in tumor tissue, microsatellite instability (MSI), tumor mutation burden (TMB) and efficacy (if applicable); * Part 2 Multiple dose exploration phase. * The primary objective of Part 2 is to evaluate the safety and tolerability of multiple intratumoral injection/intracavitary administration of GO306 in patients with specific tumors and to determine the optimal dosing regimen. * The secondary objectives of Part 2 is 1) To evaluate the pharmacokinetics (PK) and viral shedding of GO306 after multiple intratumoral injections/intracavitary administration; 2) evaluate the preliminary efficacy of multiple doses of GO306; 3) evaluate the immunogenicity of GO306; 4) To monitor the changes of immunological indicators related to GO306 pharmacodynamics. * The exploratory objectives of Part 2 is to correlation between PD-L1 expression in tumor tissue, microsatellite instability (MSI), tumor mutation burden (TMB) and efficacy (if applicable).

Conditions

• Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	GO306	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.

Timeline

• Start date: 2025-07-31
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-08-19
• Last updated: 2025-12-19

Locations

6 sites across 1 country: China