Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04890587
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2021-04-26
Brief Title:
A Phase I Study of AL8326 in Advanced Solid Tumor
Sponsor:
Advenchen Laboratories Nanjing Ltd
Organization:
Advenchen Laboratories LLC
Study Overview
Official Title:
A Dose Escalation Tolerance and Pharmacokinetics Study of AL8326 in Advanced Solid Tumor
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
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:
1 Main purpose Objective to study the tolerance and safety of single and multiple administration of repeated 28-day cycles of AL8326 in patients with advanced solid tumor observe the dose limiting toxicity DLT and maximum tolerated dose MTD
2 Secondary purpose 1 Preliminary analysis of the pharmacokinetic characteristics and efficacy of repeated 28-day cycles of AL8326 tablets in patients with advanced solid tumors 2 According to the results of phase I tolerance test and pharmacokinetics appropriate dosage and regimen were recommended for phase II clinical trial
2 Secondary purpose 1 Preliminary analysis of the pharmacokinetic characteristics and efficacy of repeated 28-day cycles of AL8326 tablets in patients with advanced solid tumors 2 According to the results of phase I tolerance test and pharmacokinetics appropriate dosage and regimen were recommended for phase II clinical trial
Detailed Description:
This is a Phase 1 study to evaluate the safetyand efficacy of 28-day cycles of AL8326 therapy The study is divided into three parts
1 Part I To evaluate the dose limiting toxicity DLT and general safety during the first 28-day cycle of Al8326 therapy and to evaluate the MTD It will include a evaluation of 3 subjects per cohort in a 33 design in
2 Part II Subject will receive a dose from Part 1 of this study for continuous 28-Day cycles of therapy
3 Part III This design adopts 3 3 dose de-escalation method for exploration At the same time the safety tolerance and pharmacokinetics were observed
1 Part I To evaluate the dose limiting toxicity DLT and general safety during the first 28-day cycle of Al8326 therapy and to evaluate the MTD It will include a evaluation of 3 subjects per cohort in a 33 design in
2 Part II Subject will receive a dose from Part 1 of this study for continuous 28-Day cycles of therapy
3 Part III This design adopts 3 3 dose de-escalation method for exploration At the same time the safety tolerance and pharmacokinetics were observed
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