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RECRUITING
NCT06352359
PHASE1

Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors

Sponsor: OncoC4, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase I/II open label study of intravenous (IV) infusion of ONC-841 as a single agent or in combination in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841. The Phase 1 part is dose escalation with 7 dose levels of ONC-841 and the dose expansion in the last dose level. The Phase 2 part will test the combination of ONC-841 with SOC in GBM and in CRC.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-08-23

Completion Date

2027-09-30

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DRUG

ONC-841

ONC-841 (anti-SIGLEC10) is a humanized antibody that binds to human sialic acid-binding Ig-like lectin 10 and has a human immunoglobulin G4 (IgG4) Fc domain.

Locations (8)

University of California at Davis Cancer Center

Sacramento, California, United States

UF Health Cancer Center, University of Florida

Gainesville, Florida, United States

AdventHealth Medical Group Oncology Research at Celebration

Kissimmee, Florida, United States

Norton Cancer Center

Louisville, Kentucky, United States

Rogel Cancer Center, University of Michigan

Ann Arbor, Michigan, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States