Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination with Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open-label Phase IA/IB/II Study (PSCI# 21-059)
The main purpose of the study is to determine whether the study drug, ONC-392, either given alone or in combination with a standard of care drugs, is safe and tolerated and how it is processed in the blood of patients with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body.
If you take part in this research, you will be responsible for: • Following all instructions given to you. If you are unsure about what you are supposed to do, ask your study team. • Coming to all your scheduled study visits and procedures. Let your study team know as soon as possible if you are not able to attend a study visit so that they can work with you to make other arrangements. • Informing the study team of all information regarding your health and medications and any health changes, procedures, emergency room visits or hospitalizations. • Not taking any other drugs or medicines unless the study doctor has approved them beforehand. Consult with the study doctor before starting any new medications or over the counter herbal/natural supplements that you buy without a prescription. • If you see a doctor or health care provider outside the research study, telling that doctor or health care provider that you are in an investigational research study. • Not participating in another investigational research study at the same time. • Telling the study staff if you wish to stop taking part in the study. • Telling the study staff immediately if you are pregnant, suspect to be pregnant or have not followed the required birth control measures. Your responsibility to follow these instructions is important to your safety. It also helps the researchers understand how the study drug works.
Patient can be male or female; female participants must have a negative pregnancy test
Patient must have an ECOG score <= 1
Patient must have a histological or cytological diagnosis of solid tumors and progressive metastatic disease or progressive locally advanced disease
Patient must have adequate organ function as determined by laboratory tests
Patients who are currently enrolled in any other clinical trial testing an investigational drug or device, or with concurrent other systemic cancer therapeutics
Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent for at least 4 weeks prior to treatment
Patients who have active brain metastases or leptomeningeal metastases
Patients who have an active infection requiring systemic IV antibiotics within 14 days prior to administration of ONC-392 or combined ONC-392 and Pembrolizumab