The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part. This study will evaluate the efficacy of TSN1611 at RP2D(s) through ORR using RECIST version 1.1, and determine and confirm the MTD/RP2D for TSN1611 in combination with cetuximab, in combination with cetuximab and mFOLFOX6, in combination with gemcitabine and albumin-bound paclitaxel in subjects with selected solid tumors.
The subject fully understands the requirements of the study and voluntarily signs the ICF.
At least 18 years of age at the time of informed consent.≤ 75 years of age for Cohort B and C.
Life expectancy of 3 months or more.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Leptomeningeal disease or Active central nervous system (CNS) metastases.
Prior systemic anti-cancer treatment within 21 days or 5 half-lives (whichever is shorter will be used as the criteria) prior to the first dose of study drug.
Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy within 1 week prior to the first dose of study drug.
Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia.