Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer

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

Detailed Description
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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

Official Title
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A Phase 1 Open Label Dose Ranging Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer

Conditions
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Safety Issues

Intervention / Treatment
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* Drug: RH324


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Level 1<br>RH324 | Drug: RH324<br>* polymolecular<br>|
| Experimental: Dose Level 2<br>RH324 | Drug: RH324<br>* polymolecular<br>|
| Experimental: Dose Level 3<br>RH324 | Drug: RH324<br>* polymolecular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 5 | Percentage of Adverse Events Summarized by Causality and Grade | Through Study Completion 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects with a Change from Baseline on Physical Examination and Vital Signs | Percentage of Subjects with a Clinically Relevant Change from Baseline on Physical Exam and Vital Signs | Through Study Completion 28 Days | 
| Percentage of Subjects with a Change from Baseline on Laboratory Values | Percentage of Subjects with a Clinically Relevant Change from Baseline on Blood and Urine Laboratory Values | Through Study Completion 28 Days | 
| Percentage of Subjects with a Change from Baseline on the Electrocardiogram | Percentage of Subjects with a Clinically Relevant Change from Baseline on the 12-Lead Electrocardiogram | Through Study Completion 28 Days | 
| Percentage of Subjects with a Change from Baseline in Quality of Life | Percentage of Subjects with a Clinically Relevant Change from Baseline in Quality of Life Based on the Eastern Cooperative Oncology Group Performance Status Levels | Through Study Completion 28 Days |