Trials / Unknown
UnknownNCT04423380
A Study to Investigate Safety and Tolerability of SH3051 Capsule in Patients With Advanced Solid Tumors
A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3051 Capsule in Patients With Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to determine the safety profile of SH3051 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3051 solid tumors.
Detailed description
This is a phase I, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of SH3051 capsule, a small molecule inhibitor of type I transforming growth factor-β(TGF-β) receptor serine/threonine kinase, in patients with advanced solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SH3051 capsule treatment | Starting dose 20mg,oral administered twice daily.If tolerated subsequent cohorts will test increasing doses (40mg,60mg,80mg,100mg) of SH3051. |
Timeline
- Start date
- 2020-05-14
- Primary completion
- 2021-03-01
- Completion
- 2021-05-01
- First posted
- 2020-06-09
- Last updated
- 2020-06-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04423380. Inclusion in this directory is not an endorsement.