Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512116
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
A Clinical Trial of SIBP-A17 Injection in the Treatment of Advanced Solid Tumor Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Label Multicenter Phase I Clinical Study Evaluating the Safety Tolerability and Pharmacokinetic Characteristics of SIBP-A17 Formulation for Injection in Subjects With Advanced Solid Tumors
Status:
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:
To evaluate the safety tolerability and pharmacokinetic characteristics of SIBP-A17 and determine the maximum tolerable dose MTD and phase II recommended dose RP2D
Detailed Description:
This study is an open dose expanding and indication expanding study to evaluate the safety tolerability pharmacokinetics immunogenicity preliminary anti-tumor efficacy QTQTc interval effects and explore potential biomarkers of SIBP-A17 in patients with advanced solid tumors
This study is divided into two stages and is planned to be set up six dose groups including 1 2 4 5 6 and 8 mgkg The first stage is the dose escalation stage adopting an improved 33 dose escalation design with a planned enrollment of 14-36 participants The second stage is the dose expansion stage where one or two doses are selected to enter the dose expansion phase 4 indication cohorts 20-40 late-stage solid tumor participants are enrolled in each dose group for dose expansion and 80-160 participants are planned to be enrolled in the dose expansion phase
After obtaining certain safety and pharmacokinetic data during the dose escalation phase the Safety Monitoring Committee SMC can discuss and decide whether to synchronize dose expansion
This study is divided into two stages and is planned to be set up six dose groups including 1 2 4 5 6 and 8 mgkg The first stage is the dose escalation stage adopting an improved 33 dose escalation design with a planned enrollment of 14-36 participants The second stage is the dose expansion stage where one or two doses are selected to enter the dose expansion phase 4 indication cohorts 20-40 late-stage solid tumor participants are enrolled in each dose group for dose expansion and 80-160 participants are planned to be enrolled in the dose expansion phase
After obtaining certain safety and pharmacokinetic data during the dose escalation phase the Safety Monitoring Committee SMC can discuss and decide whether to synchronize dose expansion
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