Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
NCT ID: NCT05580172
Last Updated: 2022-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
6 participants
INTERVENTIONAL
2022-06-01
2025-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Dose Level 1
RH324
RH324
polymolecular
Dose Level 2
RH324
RH324
polymolecular
Dose Level 3
RH324
RH324
polymolecular
Interventions
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RH324
polymolecular
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ReHeva Biosciences,Inc.
INDUSTRY
Responsible Party
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Locations
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Case Comprehensive Cancer Center University Hospitals
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RHV18002
Identifier Type: -
Identifier Source: org_study_id
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