Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:45 AM
Study NCT ID:
NCT07408258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors
Sponsor:
OncoC4, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
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:
ONC-783-001 is a Phase I open label, dose-escalation study for evaluating the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer.
Detailed Description:
This is a first in human study on a novel bispecific antibody, ONC-783, targeting cancer specific neoantigen CD24 on tumor cells and CD3 on T cells. CD24 is over-expressed in about 70% of solid tumors and hematological malignancies. CD24 overexpression is associated with poor prognosis. Cancer-specific neo-CD24 epitope will distinguish malignant CD24 from physiological CD24. This study is a multi-level dose escalation study with ONC-783 to test the safety, PK, and efficacy in patients with solid tumors.
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?: