Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT06352359
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2024-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors
Sponsor:
OncoC4, Inc.
Organization:
Study Overview
Official Title:
Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-03
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 is a Phase I open label, dose-escalation study of intravenous (IV) infusion of ONC-841 as a single agent in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841 starting from 0.03 mg/kg to 30 mg/kg.
Detailed Description:
ONC-841 is an investigational drug being developed as an anti-tumor treatment. ONC-841 is an antibody drug that binds to immune cells inside the tumor mass. The target molecule is Siglec10, mostly expressed on neutrophils, macrophages and lymphocytes. ONC-841 binds to Siglec10 to block the "do not eat me" signals that cancer cells give to immune system, which allow macrophages and neutrophils to "eat" the tumor cells. The study will use ONC-841 alone for cancer treatment. The study will evaluate seven dose levels of ONC-841 starting from 0.03 mg/kg to 30 mg/kg, given once every 4 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: