Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer
Checked against the public recordLast updated Oct 17, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Other
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- ReHeva Biosciences,Inc.
- Interventions being studied
- Drug: RH324
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Case Comprehensive Cancer Center University HospitalsCleveland, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 17, 2022. Always confirm current availability with the study team.