At a glance
ClinicalIndex Comparison RecordPhase 1Unknown· 51 target
Drug / intervention
HS-10381drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10381 in Patients With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating HS-10381 for Advanced Solid Tumor. Targeting 51 participants across 1 site.
Detailed Summary
HS-10381 is a small molecular, oral potent, SHP2 inhibitor. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-10381 in Patients With Advanced Solid Tumors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor
CountriesChina
Collaborators--
Timeline
Phase 1UnknownOverdue
2023202420252026
First PostedMay 2022
Enrollment StartJun 2022
Primary CompletionDec 2023
Study CompletionDec 2024
TodayJul 2026
First PostedMay 18, 2022
Enrollment StartJun 8, 2022
Primary CompletionDec 31, 2023
Study CompletionDec 31, 2024
TodayJul 1, 2026
Enrollment to primary: 1.6 yearsPosted 4.1 years ago
Interventions
HS-10381drug
Each subject will receive a single dose(C0) of HS-10381 and then repeat doses(C1, C2…) for 21-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.