Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304571
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Brief Title:
A Study of HC006 in Subjects With Advanced Solid Tumors
Sponsor:
HC Biopharma Inc
Organization:
HC Biopharma Inc
Study Overview
Official Title:
A Phase I Open-label Dose-Escalation and Dose-expansion Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetics Immunogenicity and Efficacy of HC006 in Advanced Solid Tumor Subjects
Status:
RECRUITING
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:
The purpose of this study is to characterize the safety tolerability pharmacokinetics PK Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies This study is a first-in-human FIH study of HC006 in subjects with advanced solid tumors
Detailed Description:
HC006 a novel therapeutic monoclonal antibody that specifically binds to human C-C motif chemokine receptor 8 CCR8 and is designed to selectively deplete tumor-infiltrating T regulatory cells Tregs with enhanced antibody-dependent cell-mediated cytotoxicity ADCC In mouse tumor models HC006 has demonstrated excellent antitumor activity and safety profile This first-in-human FIH study will be conducted in two parts In the Dose-Escalation part testing will be done on up to 31 subjects to determine the maximum tolerated dose MTD and the recommended dose RD In the Dose-expansion part we will evaluate the safety and efficacy of the recommended dose of HC006 in the treatment of advanced solid tumor subjects without standard therapy
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