Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298058
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-03-01
Brief Title:
A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
Sponsor:
Shanghai Institute Of Biological Products
Organization:
Shanghai Institute Of Biological Products
Study Overview
Official Title:
A Phase I Clinical Study on the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
Status:
RECRUITING
Status Verified Date:
2024-10
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:
To evaluate the safety tolerability and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose MTD and phase II recommended dose RP2D
Detailed Description:
This study is an open multi-dose increasing single and multiple doses increasing dose expanding and indication expanding study to evaluate the safety tolerability pharmacokinetics immunogenicity preliminary anti-tumor efficacy and explore potential biomarkers of SIBP-A13 in patients with advanced solid tumors
This study is divided into three 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 with a planned enrollment of 16-36 participants The second stage is the dose expansion stage where two doses are selected to enter the dose expansion phase 6-9 late-stage solid tumor participants are enrolled in each dose group for dose expansion and 12-18 participants are planned to be enrolled in the dose expansion phase The third stage is the indication expansion stage where phase II recommended dose RP2D is preliminarily determined based on the escalation and expansion of dosage in the early stage Using RP2D for indication expansion we plan to expand three indication cohorts with at least 30 participants selected for each cohort
This study is divided into three 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 with a planned enrollment of 16-36 participants The second stage is the dose expansion stage where two doses are selected to enter the dose expansion phase 6-9 late-stage solid tumor participants are enrolled in each dose group for dose expansion and 12-18 participants are planned to be enrolled in the dose expansion phase The third stage is the indication expansion stage where phase II recommended dose RP2D is preliminarily determined based on the escalation and expansion of dosage in the early stage Using RP2D for indication expansion we plan to expand three indication cohorts with at least 30 participants selected for each cohort
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