Clinical trial · Interventional
Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
A Phase 1 Open Label Dose Ranging Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
NCT05580172CI-TRIAL-00061479unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Safety Issues | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RH324 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- RH324
- interventionNames
- Drug: RH324
- type
- EXPERIMENTAL
- label
- Dose Level 2
- description
- RH324
- interventionNames
- Drug: RH324
- type
- EXPERIMENTAL
- label
- Dose Level 3
- description
- RH324
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHeo JU, Rao S, Newton HB, Dowlati A, Muzic RF Jr, Kardan A. Phase 1 Trial of Withania somnifera Leaf Extract (RH324) in Advanced Non-Small Cell Lung Cancer Including [18F]FDG PET/CT as a Short-Term Metabolic Biomarker to Assess Efficacy: A Novel Model for Assessment of Complimentary Therapies in Early Phase Human Clinical Trials. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251410182. doi: 10.1177/15347354251410182. Epub 2026 Feb 13. PMID 41685666