Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT03457532
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2018-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Study of SCC244 in Patients with Advanced MET Alterations Solid Tumors
Sponsor:
Haihe Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characters, and Preliminary Efficacy of SCC244 in Patients with Advanced MET Alterations Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-10
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 1a/1b multi-center and open label study to evaluate the safety, tolorability, pharmacokinetics and priliminary efficacy of SCC244 in advanced solid tumors patients with c-MET alteration
Detailed Description:
This is a phase I study, its purpose to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD)/ biologically effective dose (BED) and the recommended phase II dose (RP2D) of SCC244 monotherapy in patients with advanced MET alterations solid tumors;
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?:
False
Is an FDA AA801 Violation?: