This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors
This is an open-label, multicenter, Phase 1 study of LT-010391, a selective and orally bioavailable KRAS G12D degrader in participants with KRAS G12D mutant advanced solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two parts: Part A- dose escalation and Part B- dose expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
198
LT-010391 tablets, oral, once daily
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Adverse events
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs
Time frame: Up to 2 years
Dose Limiting Toxicities
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: 21 days
Pharmacokinetic parameters
Cmax will be recorded from the PK plasma samples collected.
Time frame: up to 15 weeks
Overall Response Rate (ORR)
Assess per RECIST v1.1
Time frame: up to 2 years
Duration of Response (DOR)
Assess per RECIST v1.1
Time frame: up to 2 years
Disease Control Rate(DCR)
Assess per RECIST v1.1
Time frame: up to 2 years
Progression-Free Survival (PFS)
Assess per RECIST v1.1
Time frame: up to 2 years
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