Safety IssuesPhase 1NCT05580172
Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
A Phase 1 study testing RH324 in people with Safety Issues, run by ReHeva Biosciences,Inc. at 1 site in United States.
Trial summary
Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety Issues
- What is being tested?
- RH324
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Case Comprehensive Cancer Center University Hospitals
Cleveland, Ohio, 44106
Afshin Dowlati, MD, 216-844-5181, Afshin.Dowlati@UHhospitals.org
About this study
Official title: A Phase 1 Open Label Dose Ranging Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer
Read the 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
- Conditions
- Safety Issues
- Being tested
- RH324
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RH324Drug
polymolecular
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | RH324 Receives: Drug: RH324 |
| Dose Level 2 | Experimental | RH324 Receives: Drug: RH324 |
| Dose Level 3 | Experimental | RH324 Receives: Drug: RH324 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 5
Percentage of Adverse Events Summarized by Causality and Grade
Measured: Through Study Completion 28 Days
Secondary outcomes (4)
Percentage of Subjects with a Change from Baseline on Physical Examination and Vital Signs
Percentage of Subjects with a Clinically Relevant Change from Baseline on Physical Exam and Vital Signs
Measured: Through Study Completion 28 Days
Percentage of Subjects with a Change from Baseline on Laboratory Values
Percentage of Subjects with a Clinically Relevant Change from Baseline on Blood and Urine Laboratory Values
Measured: Through Study Completion 28 Days
Percentage of Subjects with a Change from Baseline on the Electrocardiogram
Percentage of Subjects with a Clinically Relevant Change from Baseline on the 12-Lead Electrocardiogram
Measured: Through Study Completion 28 Days
Percentage of Subjects with a Change from Baseline in Quality of Life
Percentage of Subjects with a Clinically Relevant Change from Baseline in Quality of Life Based on the Eastern Cooperative Oncology Group Performance Status Levels
Measured: Through Study Completion 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReHeva Biosciences,Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580172
- Sponsor's protocol ID
- RHV18002
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Heo JU, Rao S, Newton HB, Dowlati A, Muzic RF Jr, Kardan A. Phase 1 Trial of Withania somnifera Leaf Extract (RH324) in Advanced Non-Small Cell Lung Cancer Including [18F]FDG PET/CT as a Short-Term Metabolic Biomarker to Assess Efficacy: A Novel Model for Assessment of Complimentary Therapies in Early Phase Human Clinical Trials. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251410182. doi: 10.1177/15347354251410182. Epub 2026 Feb 13.
PubMed 41685666
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open Label Dose Ranging Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05580172
- Acronym / sponsor ID
- RHV18002
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- ReHeva Biosciences,Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: RH324RH324 |
| Dose Level 2 | Experimental | Drug: RH324RH324 |
| Dose Level 3 | Experimental | Drug: RH324RH324 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- Prior use of Withania somnifera
- Phenylketonuria
- Inability to swallow capsules
- Hypersensitivity to study drug ingredients
- Unstable medical or surgical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RH324polymolecular | Drug | Dose Level 1, Dose Level 2, Dose Level 3 |
Primary outcome
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 5
Time frame: Through Study Completion 28 Days
Percentage of Adverse Events Summarized by Causality and Grade
4 secondary outcomes
Percentage of Subjects with a Change from Baseline on Physical Examination and Vital Signs
Time frame: Through Study Completion 28 Days
Percentage of Subjects with a Change from Baseline on Laboratory Values
Time frame: Through Study Completion 28 Days
Percentage of Subjects with a Change from Baseline on the Electrocardiogram
Time frame: Through Study Completion 28 Days
Percentage of Subjects with a Change from Baseline in Quality of Life
Time frame: Through Study Completion 28 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Derived from this study: PubMed 41685666Heo JU, Rao S, Newton HB, Dowlati A, Muzic RF Jr, Kardan A. Phase 1 Trial of Withania somnifera Leaf Extract (RH324) in Advanced Non-Small Cell Lung Cancer Including [18F]FDG PET/CT as a Short-Term Metabolic Biomarker to Assess Efficacy: A Novel Model for Assessment of Complimentary Therapies in Early Phase Human Clinical Trials. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251410182. doi: 10.1177/15347354251410182. Epub 2026 Feb 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RH324 in people with Safety Issues, run by ReHeva Biosciences,Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Packard (517-518-8194, Charles.packard@parexel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 5 (time frame: Through Study Completion 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05580172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.