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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580172
• Other study ID #: RHV18002
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: October 2022
• Source: ReHeva Biosciences,Inc.
• Contact: Charles Packard
• Phone: 517-518-8194
• Email: Charles.packard[@]parexel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: January 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Safety Issues

Intervention

Drug:
• RH324
polymolecular

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center University Hospitals	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
ReHeva Biosciences,Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 5	Percentage of Adverse Events Summarized by Causality and Grade	Through Study Completion 28 Days
Secondary	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	Through Study Completion 28 Days
Secondary	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	Through Study Completion 28 Days
Secondary	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	Through Study Completion 28 Days
Secondary	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	Through Study Completion 28 Days