Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05055232
Status:
UNKNOWN
Last Update Posted:
2021-09-24
First Post:
2021-09-14
Brief Title:
A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer
Sponsor:
Xuanzhu Biopharmaceutical Co Ltd
Organization:
Xuanzhu Biopharmaceutical Co Ltd
Study Overview
Official Title:
An Open-label Multicenter Phase I Dose Escalation and Expansion Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2021-09
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:
This is a multicenter open-label dose escalation and expansion human clinical study to observe the safety tolerability pharmacokinetics and pharmacodynamics of XZP-3621 in single and multiple oral administrations in advanced NSCLC subjects with ALK rearrangement or ROS1 rearrangement and to initially explore the efficacy of XZP-3621The study was divided into two parts dose escalation and dose expansion
Detailed Description:
This is a multicenter open-label dose escalation and expansion human clinical study to observe the safety tolerability pharmacokinetics and pharmacodynamics of XZP-3621 in single and multiple oral administrations in advanced NSCLC subjects with ALK rearrangement or ROS1 rearrangement and to initially explore the efficacy of XZP-3621The study was divided into two parts dose escalation and dose expansion
Dose escalation part
The purpose of this section was to determine MTD and RP2D doses in advanced NSCLC subjects with ALK rearrangement or ROS1 rearrangement detected in tumor tissue samples or blood samples test method is not limitedThe safety and PK of single dose in human subjects in each group were first studied After PK blood sample was collected 72 hours after single dose on day 1 continuous dose was administered once a day for 4 weeks to confirm the safety and pharmacokinetic characteristics of single dose and continuous dose
In this study Modified Fibonacci method was used for dose escalation One subject was enrolled at the initial dose of 50mg After that according to the 33 dose escalation principle the dose of 100mg 100 200mg 100 300mg 50 400mg 33 500mg 25 600mg 20and so on was incremented successively Starting from the 100mg Qd dose group 3 NSCLC subjects with ALK rearrangement or ROS1 rearrangement should be included per doseIf less than 3 NSCLC subjects were ALK rearrangement in any dose group due to inclusion of ROS1 and no 1 PR was observed in this group additional ALK rearrangement NSCLC subjects should be added until the requirements are met However as long as the number of subjects in the corresponding dose group who have completed DLT observations meets the 33 principle of escalation the addition of subjects to the ALK rearrangement should not affect the normal escalation of the next dose group
Dose expansion part
In the dose escalation study if 2 out of 3 ALK rearrangement NSCLC subjects have a partial response PR or complete response CR after all subjects in the dose escalation study have completed DLT evaluation and confirmed that the dose is safe that is a dose extension study is performed from this dose to the MTD dose group Each dose was reenrolled in about 15 NSCLC subjects with ALK rearrangement or ROS1 rearrangement demonstrated by Ventana immunohistochemistry or FISH or RT-PCR
Subjects were treated with XZP-3621 for a 28-day treatment cycle with continuous administration of or XZP-3621 until disease progression occurs or an intolerable toxic reaction impeding further treatment occurs or the investigator determines that the subjects current condition is unsuitable for further treatment the informed consent is withdrawn or the subject dies RECIST efficacy was evaluated once every two treatment cycles
During treatment dose adjustments both up and down can be made according to protocol based on subjects tolerance and the occurrence of adverse events related to the study drug Only one dose reduction of the study drug is permitted
Dose escalation part
The purpose of this section was to determine MTD and RP2D doses in advanced NSCLC subjects with ALK rearrangement or ROS1 rearrangement detected in tumor tissue samples or blood samples test method is not limitedThe safety and PK of single dose in human subjects in each group were first studied After PK blood sample was collected 72 hours after single dose on day 1 continuous dose was administered once a day for 4 weeks to confirm the safety and pharmacokinetic characteristics of single dose and continuous dose
In this study Modified Fibonacci method was used for dose escalation One subject was enrolled at the initial dose of 50mg After that according to the 33 dose escalation principle the dose of 100mg 100 200mg 100 300mg 50 400mg 33 500mg 25 600mg 20and so on was incremented successively Starting from the 100mg Qd dose group 3 NSCLC subjects with ALK rearrangement or ROS1 rearrangement should be included per doseIf less than 3 NSCLC subjects were ALK rearrangement in any dose group due to inclusion of ROS1 and no 1 PR was observed in this group additional ALK rearrangement NSCLC subjects should be added until the requirements are met However as long as the number of subjects in the corresponding dose group who have completed DLT observations meets the 33 principle of escalation the addition of subjects to the ALK rearrangement should not affect the normal escalation of the next dose group
Dose expansion part
In the dose escalation study if 2 out of 3 ALK rearrangement NSCLC subjects have a partial response PR or complete response CR after all subjects in the dose escalation study have completed DLT evaluation and confirmed that the dose is safe that is a dose extension study is performed from this dose to the MTD dose group Each dose was reenrolled in about 15 NSCLC subjects with ALK rearrangement or ROS1 rearrangement demonstrated by Ventana immunohistochemistry or FISH or RT-PCR
Subjects were treated with XZP-3621 for a 28-day treatment cycle with continuous administration of or XZP-3621 until disease progression occurs or an intolerable toxic reaction impeding further treatment occurs or the investigator determines that the subjects current condition is unsuitable for further treatment the informed consent is withdrawn or the subject dies RECIST efficacy was evaluated once every two treatment cycles
During treatment dose adjustments both up and down can be made according to protocol based on subjects tolerance and the occurrence of adverse events related to the study drug Only one dose reduction of the study drug is permitted
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