Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer

This is a Phase 1 open label dose ranging study to assess the safety and tolerability of oral RH324 in advanced non-small cell lung cancer

Inclusion Criteria:

• Advanced Non-Small Cell Lung Cancer
• Measurable Target Lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Failed all standard of care including chemotherapy, targeted therapy, and immunotherapy
• Adults over 18 years
• Performance status (Eastern Cooperative Oncology Group) less than or equal to 2
• Life expectancy greater than 2 months
• Laboratory Values:

Hemoglobin greater than or equal to 9; neutrophils greater than 1,000; platelets greater than 50,000 Liver function tests less than or equal to twice upper limit of normal Serum Creatinine less than or equal to 2 Creatinine clearance greater than or equal to 30 mL per minute Hemoglobin A1C less than 7 Normal Thyroid function

• No history of hyperthyroidism
• Abstinence from alcohol and supplements
• Not pregnant, lactating and willing to use birth control throughout study
• Able to provide consent
• Positive Emission Tomography/Computer Tomography part of subjects care plan at baseline

Exclusion Criteria:

• Prior use of Withania somnifera
• Phenylketonuria
• Inability to swallow capsules
• Hypersensitivity to study drug ingredients
• Unstable medical or surgical condition
• History of additional cardiac risk factors
• Requiring drugs that are "strong" inhibitors of cytochrome P450
• Requiring irradiation
• Requiring intravenous fluids or hyperalimentation
• Requiring transfusions, dialysis, or other procedures
• Active infection
• Human Immunodeficiency Virus
• Must exceed washout period of prior treatments
• Psychiatric, neurological or other reason that precludes subjects ability to participate