HS-10529 is an oral, highly selective, small molecular inhibitor of KRAS G12D. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10529 in KRAS G12D patients with advanced solid tumors.
This is a phase 1, first-in-human, study of HS-10529, consisting of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10529 in KRAS G12D patients with advanced solid tumors and evaluate the preliminary efficacy of HS-10529.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
520
Participants in all subjucts will receive HS-10529
The maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Time frame: up to 24 months
Incidence and severity of treatment-emergent adverse events
Time frame: up to 24 months
Plasma concentration of HS-10529
Time frame: up to 36 months
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