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A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3051 Capsule in Patients With Advanced Solid Tumors
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.
Details
| Lead sponsor | Nanjing Sanhome Pharmaceutical, Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 45 |
| Start date | 2020-05-14 |
| Completion | 2021-05 |
Conditions
- Advanced Solid Tumor
Interventions
- SH3051 capsule treatment
Primary outcomes
- Maximum tolerated dose(MTD) — Within the first 28 days of consecutive treatment
- Incidence of Dose Limiting Toxicity (DLT) — Within the first 28 days of consecutive treatment
Countries
China