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

NCT05580172 | Unknown Phase 1 FDA Drug

• 1 other identifier: RHV18002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Subjects with a Change from Baseline on Physical Examination and Vital Signs

  Through Study Completion 28 Days

• Percentage of Subjects with a Change from Baseline on Laboratory Values

  Through Study Completion 28 Days

• Percentage of Subjects with a Change from Baseline on the Electrocardiogram

  Through Study Completion 28 Days

• Percentage of Subjects with a Change from Baseline in Quality of Life

  Through Study Completion 28 Days

Study Arms (3)

Dose Level 1

EXPERIMENTAL

RH324

Drug: RH324

Dose Level 2

EXPERIMENTAL

RH324

Drug: RH324

Dose Level 3

EXPERIMENTAL

RH324

Drug: RH324

Interventions

RH324 DRUG

polymolecular

Dose Level 1; Dose Level 2; Dose Level 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ReHeva Biosciences,Inc.: lead

Study Sites (1)

Case Comprehensive Cancer Center University Hospitals

Cleveland, Ohio, 44106, United States

RECRUITING

Central Study Contacts

Charles Packard

CONTACT

517-518-8194; Charles.packard@parexel.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

US (1)