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

ReHeva Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Safety Issues

Treatments: Drug: RH324

Study type: Interventional

Funder types: Industry

Identifiers

NCT05580172

RHV18002

Details and patient eligibility

About

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

Full 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

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Dose Level 1

Experimental group

Description:

RH324

Treatment:

Drug: RH324

Dose Level 2

Experimental group

Description:

RH324

Treatment:

Drug: RH324

Dose Level 3

Experimental group

Description:

RH324

Treatment:

Drug: RH324