Clinical Trial Finder

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05580172
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 ReHeva Biosciences,Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Safety Issues
Additional Details

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

Arms & Interventions

Arms

Experimental: Dose Level 1

RH324

Experimental: Dose Level 2

RH324

Experimental: Dose Level 3

RH324

Interventions

Drug: - RH324

polymolecular

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Recruiting

Address

Case Comprehensive Cancer Center University Hospitals

Cleveland, Ohio, 44106

Site Contact

Afshin Dowlati, MD

[email protected]

216-844-5181

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with a healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with site contacts or other relevant parties. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage trial participants to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.