This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HS387 in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
HS387 tablets will be given orally
Zhejiang Cancer hospital
Hangzhou, Zhejiang, China
RECRUITINGNumber of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)
Adverse events (AE), serious adverse events (SAE), and severity of AE using the NCI-CTCAE version 5.0
Time frame: 2 years
Dose-limiting Toxicities Incidence Count Among Study Participant
DLT refers to Dose-Limiting Toxicity. It is defined as a side effect or adverse reaction of a drug or treatment that is severe enough to prevent an increase in dosage. Identifying DLT is crucial in clinical trials for determining the maximum tolerated dose (MTD) of a new drug.
Time frame: 2 years
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