Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346041
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-12
Brief Title:
Safety and Efficacy of Intravenous IDOV-SAFETM 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 Phase I Study of Evaluating the Safety and Efficacy of Intravenous IDOV-SAFETM 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:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label dose escalation phase I study to evaluate safety tolerability MTD or MFD pharmacokinetic profile immunogenicity and pharmacodynamic profile of IDOV-SAFETM in patients with advanced solid tumors
Detailed Description:
The study is a single agent dose escalation which will use an accelerated and 33 design to evaluate escalating doses of IDOV-SAFETMTotal enrollment will depend on the toxicities andor activity observed with approximately 13-19 evaluable participants enrolled A Dose-Limiting Toxicity DLT observation period of 3weeks was established before the entry of the first patient at the next dose level After all subjects in the current dose group have completed the DLT observation period the administration of the next dose group can only be started if the condition of dose escalation is met
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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