Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645301
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
BGT007 Treatment for Recurrentrefractory Gastrointestinal Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploratory Clinical Study Initiated by Researchers on the Safety and Preliminary Efficacy of BGT007 in Treating Patients with Recurrentrefractory Gastrointestinal Malignancies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This study is an exploratory research on single arm open and improved 33 dose escalation BGT007 will explore two dose groups namely Group A 30X10 8 3 cases Group B 60X10 8 3 cases and receive the same dose infusion after observing lower adverse reactions and initial benefits SD or PR with an interval of one month Each subject can receive a maximum of 3 infusions in total
Detailed Description:
Main research objectives
Evaluate the safety and tolerability of BGT007 in treating patients with recurrentrefractory multiple gastrointestinal malignancies
Secondary research objective
1 Evaluate the pharmacokinetic PK characteristics of BGT007
2 Evaluate the preliminary effectiveness of BGT007 product
Evaluate the safety and tolerability of BGT007 in treating patients with recurrentrefractory multiple gastrointestinal malignancies
Secondary research objective
1 Evaluate the pharmacokinetic PK characteristics of BGT007
2 Evaluate the preliminary effectiveness of BGT007 product
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