Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172309
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2023-11-23
Brief Title:
A Phase I Study of NTQ1062 in Chinese Patients With Advanced Solid Tumors
Sponsor:
Nanjing Chia-tai Tianqing Pharmaceutical
Organization:
Nanjing Chia-tai Tianqing Pharmaceutical
Study Overview
Official Title:
A Phase I Study of Safety Tolerability Pharmacokinetics and Preliminary Pharmacodynamic Effect of NTQ1062 Tablets in Chinese Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-07
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 single-arm phase 1 study to evaluate the safety tolerability pharmacokinetics and preliminary pharmacodynamic effect of NTQ1062 in patients with advanced solid tumors
The study comprises a dose-escalation phase and a dose-expansion phase
1 Dose-escalationusing 33 design to evaluate the safety tolerability and pharmacokinetic profile of NTQ1062 at 20 50 100 200 300 400 mg in patients with advanced solid tumors and to determine the maximum tolerated dose MTD
2 Dose-expansionthe dose-expansion study will evaluate the safety tolerability and preliminary pharmacodynamic effect of the MTD for NTQ1062 in patients with advanced solid tumors and to identify the recommended phase 2 dose RP2D
The study comprises a dose-escalation phase and a dose-expansion phase
1 Dose-escalationusing 33 design to evaluate the safety tolerability and pharmacokinetic profile of NTQ1062 at 20 50 100 200 300 400 mg in patients with advanced solid tumors and to determine the maximum tolerated dose MTD
2 Dose-expansionthe dose-expansion study will evaluate the safety tolerability and preliminary pharmacodynamic effect of the MTD for NTQ1062 in patients with advanced solid tumors and to identify the recommended phase 2 dose RP2D
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