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

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

Study Overview

• Status: Recruiting
• Conditions: Safety Issues
• Intervention / Treatment: Drug: RH324

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 Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Charles Packard; Phone Number: 517-518-8194; Email: Charles.packard@parexel.com

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Case Comprehensive Cancer Center University Hospitals
      • Contact: Afshin Dowlati, MD; Phone Number: 216-844-5181; Email: Afshin.Dowlati@UHhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Level 1; RH324	Drug: RH324; polymolecular
Experimental: Dose Level 2; RH324	Drug: RH324; polymolecular
Experimental: Dose Level 3; RH324	Drug: RH324; polymolecular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: ReHeva Biosciences,Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: RHV18002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No