A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer

Study Overview
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Brief Summary
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A Phase I study of SH003 for evaluate safe dose range in patients with solid cancer. The first dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated. The second dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated. The third dose group receives SH003 for 3 weeks.

Official Title
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A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer

Conditions
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Solid Tumor, Adult

Intervention / Treatment
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* Drug: SH003


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years or older Patients with histologically and cytologically confirmed solid tumor Patients who have failed standard treatments, such as previous chemotherapy or radiotherapy, or who are inoperable, refractory, or progressive. ECOG score 0-2 Patients with a minimum life expectancy of 12 weeks at the scheduled starting date of the study drug Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects. Patients who can swallow pills. Patients who provide written informed consent for participation in the trial Exclusion Criteria: Known hypersensitivity to any study drug component, including Astragalus membranaceus, Angelica gigas, or Trichosanthes Kirilowii Maximowicz Patients with pre-existing cardiac conditions: Prior documented myocardial infarction within the last 6 months Pre-existing cardiac failure (NYHA class III-IV) Atrial fibrillation on anti-coagulants Unstable angina Severe valvulopathy Cardiac angioplasty or stenting with in the last 6 months Pregnant or lactating females Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety Active uncontrolled infection, including known history of AIDS or hepatitis B or C Any psychological, sociological, or geographical condition that could potentially interfere with compliance with the study protocol Concurrently receiving any other investigational agents while on study

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SH003<br>Participant will take SH003 for 3 weeks. | Drug: SH003<br>* Herbal medicine for cancer treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Grade 3-4 adverse event using CTCAE v4.03 | 3 weeks |