This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors
Participants with histologically or cytologically confirmed advanced solid tumors harboring a KRAS G12D mutation;
Failed standard therapy, intolerant to standard therapy, or no standard therapy is available;
ECOG Performance Status of 0 or 1;
Adequate organ function
History of ≥2 primary malignancies within 5 years prior to signing informed consent, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies considered cured;
Primary central nervous system (CNS) tumors
leptomeningeal metastases, brainstem metastases, or spinal cord compression confirmed by imaging (regardless of symptoms) Other inclusion/exclusion criteria may apply.
Single group
LT-010391
DrugLT-010391 tablets, oral, once daily
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
Dose Limiting Toxicities
Number of participants with Dose Limiting Toxicities (DLTs)
Pharmacokinetic parameters
Cmax will be recorded from the PK plasma samples collected.
Overall Response Rate (ORR)
Assess per RECIST v1.1
Duration of Response (DOR)
Assess per RECIST v1.1
Disease Control Rate（DCR）
Assess per RECIST v1.1
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