Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404905
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-19
Brief Title:
Clinical Trial of BT02 in Patients With Advanced Solid Tumors
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
A First-in-Human Open Label Phase III Study to Evaluate the Safety Tolerability Pharmacokinetics Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
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:
BT02
Brief Summary:
A First-in-Human Open Label Phase III Study to Evaluate the Safety Tolerability Pharmacokinetics Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors
Detailed Description:
Overall study design
This is an open-label FIH Phase I II study of BT02 to evaluate the safety tolerability PK immunogenicity and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors
Safety monitoring committee SMC will be appointed for this study The SMC includes the PIs sub-Is sponsor representatives and or independent experts to monitor the safety and scientific integrity of a human research intervention and to make recommendations to the sponsor to continue amend or stop the study based on safety findings efficacy or for futility The medical monitor will conduct a monthly systematic medical monitoring of the data during the study
This is an open-label FIH Phase I II study of BT02 to evaluate the safety tolerability PK immunogenicity and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors
Safety monitoring committee SMC will be appointed for this study The SMC includes the PIs sub-Is sponsor representatives and or independent experts to monitor the safety and scientific integrity of a human research intervention and to make recommendations to the sponsor to continue amend or stop the study based on safety findings efficacy or for futility The medical monitor will conduct a monthly systematic medical monitoring of the data during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None