Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05257512
Status:
RECRUITING
Last Update Posted:
2023-02-14
First Post:
2022-02-09
Brief Title:
Phase III Study of SY-3505 in Patients With ALK-positive Advanced Non-small Cell Lung Cancer
Sponsor:
Shouyao Holdings Beijing Co LTD
Organization:
Shouyao Holdings Beijing Co LTD
Study Overview
Official Title:
A Phase III Open-label Multicenter Study of the Safety Pharmacokinetics and Antitumor Activity of SY-3505 Capsule in Patients With ALK-positive Advanced Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2023-02
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 a phase III open-label and multi-center study of SY-3505 a third-generation ALK TKI in patients with advanced ALK-positive non-small cell lung cancer ALK-positive NSCLC
Detailed Description:
The study consists of two parts
Part 1 Dose-escalation and dose-expansion in patients with advanced ALK-positive NSCLC including 9 SY-3505 dose levels
Dose-escalation study phase is designed to determine the dose-limiting toxicity DLT according to a 33 design and recommended phase II dose RP2D and to characterize the safety tolerability and pharmacokinetics PK profile of SY-3505 Other dose regimens may be explored based on the analysis of emerging PK and safety data At this study phase SY-3505 administered orally once daily QD in 28-day treatment cycles to adult patients with ALK-positive NSCLC Dose-expansion study is designed to evaluate the antitumor activity ORR DCR and DoR of SY-3505 at selected doses in ALK-positive NSCLC patients who have received at least 1 prior ALK TKI therapy
Part 2 Phase 2 study to evaluate the efficacy of SY-3505
This phase is designed to determine the antitumor activity ORR DCR DoR PFS and OS safety and PK of SY-3505 at RP2D in ALK-positive NSCLC patients who have received alectinib only or 2 prior ALK TKIs
Part 1 Dose-escalation and dose-expansion in patients with advanced ALK-positive NSCLC including 9 SY-3505 dose levels
Dose-escalation study phase is designed to determine the dose-limiting toxicity DLT according to a 33 design and recommended phase II dose RP2D and to characterize the safety tolerability and pharmacokinetics PK profile of SY-3505 Other dose regimens may be explored based on the analysis of emerging PK and safety data At this study phase SY-3505 administered orally once daily QD in 28-day treatment cycles to adult patients with ALK-positive NSCLC Dose-expansion study is designed to evaluate the antitumor activity ORR DCR and DoR of SY-3505 at selected doses in ALK-positive NSCLC patients who have received at least 1 prior ALK TKI therapy
Part 2 Phase 2 study to evaluate the efficacy of SY-3505
This phase is designed to determine the antitumor activity ORR DCR DoR PFS and OS safety and PK of SY-3505 at RP2D in ALK-positive NSCLC patients who have received alectinib only or 2 prior ALK TKIs
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