Ignite Creation Date:
2025-12-18 @ 9:55 AM
Ignite Modification Date:
2025-12-18 @ 9:55 AM
Study NCT ID:
NCT07128914
Status:
None
Last Update Posted:
2025-08-19 00:00:00
First Post:
2025-07-14 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study of GO306 in Patients With Advanced Solid Tumors
Sponsor:
None
Organization:
Study Overview
Official Title:
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:
None
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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).
* 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: