Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors

Inclusion Criteria

• •Age ≥ 18 yrs old.
• •Male or Female
• •Must have ECOG score ≤ 1. The body weight should be ≥40 kg. The life expectance should be estimated ≥ 12 weeks.
• •A histological or cytological diagnosis of metastatic or locally advanced pancreatic cancer, ovarian cancer, colorectal cancer, or breast cancer.
• •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 of childbearing potential: negative pregnancy test and agreement on highly effective contraceptive methods.
• •Male patient: agreement on contraceptive methods.
• •Patient with a different cancer other than the one treated under this protocol, which requires systemic treatments within 24 months prior to C1D1.
• •Patient has history of Grade ≥3 allergic or hypersensitivity to SC injected medications, or severe allergic reactions to food, pollen, oral medications, or atopic dermatitis or asthmatic episodes that required hospitalization.
• •QTcF (QT interval corrected for heart rate using Fridericia formula) \>480 msec on screening ECG
• •Within past 6 months with history of significant cardiovascular events including acute myocardial infarction, acute coronary syndrome, ischemic or hemorrhagic stroke, heart failure NYHA class III or IV, or revascularization procedures.
• •Patients who have acute infections which require systemic IV drug treatments within 7 days prior to C1D1. Oral drug or prophylaxis treatment is allowed.
• •Patients who, in the opinion of the treating Investigator, have a history or current evidence of any medical or psychiatric conditions that would limit their ability to comply with all aspects of the trial or on a therapy, or with a significant laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make study participation not in the best interest of the patient. Investigators should discuss the case with the Sponsor.
• •Patients who are pregnant or breastfeeding, or who intend to become pregnant or father a child during the study or within 6 months after the last dosing of study drug.