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UnknownPhase 1NCT05580172
Official study title

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

Study summary

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

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedRH324

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 17, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?ReHeva Biosciences,Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Other
Study type
Interventional
Phase
Phase 1
Sponsor
ReHeva Biosciences,Inc.
Interventions being studied
Drug: RH324
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Case Comprehensive Cancer Center University HospitalsCleveland, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 17, 2022. Always confirm current availability with the study team.

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