Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508307
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-26
Brief Title:
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Study Evaluating the Safety Tolerability Biodistribution and Shedding of the Virus Pharmacodynamics Immunogenicity and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patient With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present trial is an open single-arm phase I clinical study aimed at assessing the safety tolerability viral distribution and shedding patterns pharmacodynamics immunogenicity and antitumor efficacy of GC001 oncolytic virus injection in patients with advanced solid tumors following a single administration
Detailed Description:
The main objective of this study is
To evaluate the safety and tolerability ie dose limiting toxicity DLT maximum tolerated dose MTD or maximum administered dose MFD of GC001 injection in patients with advanced solid tumors
The ongoing trial is structured as an open single-arm Phase I clinical study The initial phase of the study Part I utilizes a 33 design to meticulously evaluate the escalation of the dose of GC001 The total enrollment of participants will be determined by the observed toxicity levels and the extent of dose cohorts explored with an anticipated enrollment ranging from 21 to 36 eligible individuals A critical 28-day period post-administration has been established for the observation of dose-limiting toxicities DLTs to ensure participant safety It is essential to maintain this standardized 28-day observation window for all enrolled groups to uphold the highest safety standards
The secondary aims of this investigation are to assess the biodistribution and shedding of the virus the pharmacodynamic characteristics immunogenicity and the initial antitumor efficacy of the GC001 injection in patients suffering from advanced solid tumors These objectives are integral to understanding the broader impact and potential of the treatment in this patient population
Following the completion of the DLT assessment for all participants within each dose cohort the SMC may decide whether to proceed with dose escalation explore intermediatehigher doses or terminate the dose escalation study based on the data obtained on safety tolerability biodistribution and shedding of the virus if any pharmacodynamics if any immunogenicity if any and antitumor activity if any The SMC may also decide to adjust doses administration schedules and the time of biospecimen collection
To evaluate the safety and tolerability ie dose limiting toxicity DLT maximum tolerated dose MTD or maximum administered dose MFD of GC001 injection in patients with advanced solid tumors
The ongoing trial is structured as an open single-arm Phase I clinical study The initial phase of the study Part I utilizes a 33 design to meticulously evaluate the escalation of the dose of GC001 The total enrollment of participants will be determined by the observed toxicity levels and the extent of dose cohorts explored with an anticipated enrollment ranging from 21 to 36 eligible individuals A critical 28-day period post-administration has been established for the observation of dose-limiting toxicities DLTs to ensure participant safety It is essential to maintain this standardized 28-day observation window for all enrolled groups to uphold the highest safety standards
The secondary aims of this investigation are to assess the biodistribution and shedding of the virus the pharmacodynamic characteristics immunogenicity and the initial antitumor efficacy of the GC001 injection in patients suffering from advanced solid tumors These objectives are integral to understanding the broader impact and potential of the treatment in this patient population
Following the completion of the DLT assessment for all participants within each dose cohort the SMC may decide whether to proceed with dose escalation explore intermediatehigher doses or terminate the dose escalation study based on the data obtained on safety tolerability biodistribution and shedding of the virus if any pharmacodynamics if any immunogenicity if any and antitumor activity if any The SMC may also decide to adjust doses administration schedules and the time of biospecimen collection
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?:
None