Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431243
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-20
Brief Title:
A Clinical Study of Puesta Mesylate for Injection in Patients With Solid Tumors
Sponsor:
Chengdu Zenitar Biomedical Technology Co Ltd
Organization:
Chengdu Zenitar Biomedical Technology Co Ltd
Study Overview
Official Title:
An Open Multicenter Phase IbIIa Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of the Combination of Puesta Mesylate for Injection in the Treatment of Advanced Solid Tumors
Status:
NOT_YET_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:
Primary Purpose Phase Ib Evaluate the safety and tolerability of the combination of puesta mesylate in the treatment of advanced solid tumors and explore the dose-limiting toxicity DLT and maximum tolerated dose MTD of the combination of puesta mesylate in patients with advanced solid tumors Determine the recommended phase II dose RP2D for the combination of puesta mesylate in the treatment of advanced solid tumors
Phase IIa To further evaluate the preliminary efficacy of the combination of puesta mesylate in patients with advanced solid tumors
Secondary objective Phase Ib Evaluate the safety and tolerability of poystat mesylate monotherapy in advanced solid tumors To evaluate the preliminary efficacy of the combination of poystat mesylate in patients with advanced solid tumors To evaluate the pharmacokinetic profile of the combination of puesta mesylate in the treatment of advanced solid tumors
Phase IIa To further evaluate the safety and tolerability of the combination of puesta mesylate in the treatment of advanced solid tumors To evaluate the pharmacokinetic profile of the combination of puesta mesylate in the treatment of advanced solid tumors
Exploratory Objective To evaluate the pharmacodynamic significance of biomarkers in the combination of puesta mesylate for the treatment of advanced solid tumors
Phase IIa To further evaluate the preliminary efficacy of the combination of puesta mesylate in patients with advanced solid tumors
Secondary objective Phase Ib Evaluate the safety and tolerability of poystat mesylate monotherapy in advanced solid tumors To evaluate the preliminary efficacy of the combination of poystat mesylate in patients with advanced solid tumors To evaluate the pharmacokinetic profile of the combination of puesta mesylate in the treatment of advanced solid tumors
Phase IIa To further evaluate the safety and tolerability of the combination of puesta mesylate in the treatment of advanced solid tumors To evaluate the pharmacokinetic profile of the combination of puesta mesylate in the treatment of advanced solid tumors
Exploratory Objective To evaluate the pharmacodynamic significance of biomarkers in the combination of puesta mesylate for the treatment of advanced solid tumors
Detailed Description:
None
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