Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors
OncoC4, Inc.
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.
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 given once every 4 weeks.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Must have ECOG score ≤ 1. The body weight should be ≥40 kg. * A histological or cytological diagnosis of solid tumors and metastatic disease or locally advanced disease. * Must have measurable target lesion according to RECIST V1.1. * Adequate organ function as determined by laboratory tests. * Voluntary agreement to participate as evidenced by written informed consent. * Female patient: negative pregnancy test and agreement on contraceptive methods. * Male patient: agreement on contraceptive methods. * Agree to give archival or other diagnostic tissue recut slides or an…
Interventions
- DrugONC-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 CenterSacramento, California
- UF Health Cancer Center, University of FloridaGainesville, Florida
- AdventHealth Medical Group Oncology Research at CelebrationKissimmee, Florida
- Norton Cancer CenterLouisville, Kentucky
- Rogel Cancer Center, University of MichiganAnn Arbor, Michigan
- Thomas Jefferson University HospitalPhiladelphia, Pennsylvania