Clinical trial NCT05580172: Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
Official title: A Phase 1 Open Label Dose Ranging Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Safety Issues
Lead sponsor: ReHeva Biosciences,Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 5
timeFrame: Through Study Completion 28 Days
Secondary outcomes:
measure: Percentage of Subjects with a Change from Baseline on Physical Examination and Vital Signs
timeFrame: Through Study Completion 28 Days
measure: Percentage of Subjects with a Change from Baseline on Laboratory Values
timeFrame: Through Study Completion 28 Days
measure: Percentage of Subjects with a Change from Baseline on the Electrocardiogram
timeFrame: Through Study Completion 28 Days
measure: Percentage of Subjects with a Change from Baseline in Quality of Life
timeFrame: Through Study Completion 28 Days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center University Hospitals
state: Ohio
Study officials:
References: