Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors

A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-010391 Tablets in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.