Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
Study NCT ID:
NCT03466268
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2017-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Anti-tumor Activity of SCC244
Sponsor:
Haihe Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Trial to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of SCC244 in Subjects With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-03
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 study evaluates the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of SCC244 in patients with advanced solid tumors with c-Met Alterations.
Detailed Description:
A Phase I Dose Escalation and Dose Expansion Trial to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCC244, a Highly Selective c-Met Inhibitor, in Patients with Advanced Non-small Cell Lung Cancer.
Phase Ia: The primary objective is to determine the MTD, BED and recommended dose for Phase Ib in patients with advanced NSCLCs. In addition, the safety, tolerability, preliminary efficacy and PK of SCC244 and its metabolites will also be evaluated. In phase Ia, planned dose levels will be evaluated with a starting dose of 100mg.
Phase Ib: The primary objective is to assess the ORR in advanced NSCLC patients with c-MET change. The DOR, DCR, TTR, PFS, one-year OS rate, safety, tolerability, and PK will also be evaluation in Phase Ib.
Phase Ia: The primary objective is to determine the MTD, BED and recommended dose for Phase Ib in patients with advanced NSCLCs. In addition, the safety, tolerability, preliminary efficacy and PK of SCC244 and its metabolites will also be evaluated. In phase Ia, planned dose levels will be evaluated with a starting dose of 100mg.
Phase Ib: The primary objective is to assess the ORR in advanced NSCLC patients with c-MET change. The DOR, DCR, TTR, PFS, one-year OS rate, safety, tolerability, and PK will also be evaluation in Phase Ib.
Study Oversight
Has Oversight DMC:
True
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?: