Trials / Unknown
UnknownNCT03618043
Safety and Tolerability of SH-1028 in Patients With Advanced Solid Cancer
A Phase I, Open-label Study to Assess the Safety and Tolerability of Ascending Doses of SH-1028 Tablets in Patients With Advanced Solid Cancer
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1, open-label study of SH-1028 with dose escalation cohorts in locally advanced solid cancer patients who have progressed following prior therapy with an epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor (TKI) agent or standard treatment.
Detailed description
The study is designed to evaluate safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of once-daily and orally (PO) administered SH-1028 tablets. The overall study design is shown in the flow chart below.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SH-1028 | Starting dose 60mg,oral administered once daily.If tolerated subsequent cohorts will test increasing doses (120mg,180mg,240mg,320mg) of SH-1028. |
Timeline
- Start date
- 2018-09-13
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2018-08-07
- Last updated
- 2019-01-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03618043. Inclusion in this directory is not an endorsement.