A Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy ofONC-783 in Advanced Solid Tumors

This research study is a first-in-human Phase 1 study. The study tests the effects of study drug, ONC-783, in the treatment of advanced or metastatic colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer. The most important measurement for the study is to see whether ONC-783 is safe and tolerable, how it is processed in the blood/body and whether it could slow down tumor growth. ONC-783 is an investigational drug being developed as an anti-tumor treatment. ONC-783 is a bispecific antibody drug, which means it may bring immune cells (that protect the body against diseases) and cancer cells close together. This may help activate the immune cells, and may enable them to release substances that can kill cancer cells. ONC-783 is an experimental drug and has not been approved by the U.S. Food and Drug Administration (FDA), or other Agencies outside the U.S. for the treatment of any disease or type of tumor. All participants will receive the study drug.

Are you Eligible? (Inclusion Criteria)

• • Age ≥ 18 yrs old. • Male or Female. • Voluntary agreement to participate as evidenced by written informed consent.