Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352359
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-02
Brief Title:
Safety Pharmacokinetics PK and Efficacy of ONC 841 in Advanced Solid Tumors
Sponsor:
OncoC4 Inc
Organization:
OncoC4 Inc
Study Overview
Official Title:
Safety Pharmacokinetics PK and Efficacy of ONC 841 in Advanced Solid Tumors
Status:
RECRUITING
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 I open label dose-escalation study of intravenous IV infusion of ONC-841 as a single agent in patients with advancedmetastatic solid tumors The study will evaluate seven dose levels of ONC-841 starting from 003 mgkg to 30 mgkg
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 003 mgkg to 30 mgkg given once every 4 weeks
Study Oversight
Has Oversight DMC:
None
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?:
None