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Trial Title:
Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
NCT ID:
NCT05580172
Condition:
Safety Issues
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RH324
Description:
polymolecular
Arm group label:
Dose Level 1
Arm group label:
Dose Level 2
Arm group label:
Dose Level 3
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Case Comprehensive Cancer Center University Hospitals
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Afshin Dowlati, MD
Phone:
216-844-5181
Email:
Afshin.Dowlati@UHhospitals.org
Start date:
June 1, 2022
Completion date:
January 1, 2025
Lead sponsor:
Agency:
ReHeva Biosciences,Inc.
Agency class:
Industry
Source:
ReHeva Biosciences,Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05580172
