Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 1:05 PM
Study NCT ID:
NCT05233332
Status:
UNKNOWN
Last Update Posted:
2023-05-31
First Post:
2022-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC)
Sponsor:
Shanghai Kechow Pharma, Inc.
Organization:
Study Overview
Official Title:
A Phase Ⅱ, Multicenter Open-label Study to Investigate the Efficacy and Safety of HL-085 Combined With Vemurafenib in Patients With Metastatic Colorectal Cancer (mCRC)
Status:
UNKNOWN
Status Verified Date:
2023-05
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:
mCRC
Brief Summary:
The study consists of the two parts, phase IIa and phase IIb.
Detailed Description:
The study consists of the two parts, phase IIa and phase IIb. Phase IIa study is to assess the safety and the antitumor activity in patients with mCRC and to recommend reasonable dosage regimen of HL-085 for phase IIb study. Phase IIb is a pivotal study to evaluate HL-085 plus Vemurafenib in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting.
Study Oversight
Has Oversight DMC:
False
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?: