Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466265
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-12
Brief Title:
Study of DNP002 in Patients With Solid Tumors
Sponsor:
Kumho HT Inc
Organization:
Kumho HT Inc
Study Overview
Official Title:
An Open-label Dose-finding Phase I Study to Assess the Safety Tolerability and Pharmacokinetic Profile of DNP002 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-06
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 an open-label Phase 1 first-in-human dose-escalation study designed to assess the safety tolerability pharmacokinetics and preliminary efficacy of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6 CEACAM6 antibody DNP002 in patients with advanced solid tumors
Detailed Description:
The primary objectives of this study are to evaluate the safety and tolerability of DNP002 in patients with advanced solid tumors and to determine the maximum tolerated dose MTD and recommended phase 2 dose RP2D The secondary objectives are to evaluate the pharmacokinetic properties and preliminary anti-tumor effects in patients with solid tumors The exploratory objectives are to analyze the expression and relationship with efficacy of various tumor and blood biomarkers
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