Clinical trial · Interventional
A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer
NCT03081819CI-TRIAL-00040509completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SH003 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SH003
- description
- Participant will take SH003 for 3 weeks.
- interventionNames
- Drug: SH003
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- 3 weeks
- description
- Grade 3-4 adverse event using CTCAE v4.03
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDCheon C, Ko SG. A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420911442. doi: 10.1177/1534735420911442. PMID 32186413
- DERIVEDCheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Single-arm, open-label, dose-escalation phase I study to evaluate the safety of a herbal medicine SH003 in patients with solid cancer: a study protocol. BMJ Open. 2018 Aug 5;8(8):e019502. doi: 10.1136/bmjopen-2017-019502. PMID 30082340