Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors
Trial Parameters
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Brief Summary
This is a Phase I open label, dose-escalation study of intravenous (IV) infusion of ONC-841 as a single agent in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841 starting from 0.03 mg/kg to 30 mg/kg.
Eligibility Criteria
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 optional new tumor biopsy. Exclusion Criteria: * Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled endocrine immune-related AEs are considered stable and eligible for enrollment. * The washout period for