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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    6
  • sponsor
    ReHeva Biosciences,Inc.
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Updated on 24 October 2022
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Summary

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

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

Details
Condition Safety Issues
Treatment RH324
Clinical Study IdentifierNCT05580172
SponsorReHeva Biosciences,Inc.
Last Modified on24 October 2022

Eligibility

 Yes No Not Sure

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
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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