This is a first-in-human (FIH), exploratory, multicenter, open-label, phase I/II study of ABSK141 in patients with advanced solid tumors to to evaluate safety, tolerability, PK and optimize the dosage.
Patients should understand, sign, and date the written informed consent form prior to screening
Male or female age 18 years or older
Patients with histologically confirmed locally-advanced or metastatic solid tumors .
Colorectal cancer (CRC);
Known allergy or hypersensitivity to any component of the investigational product
(For backfill cohorts and expansion part) Patients who were previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy
Has a known additional malignancy that is progressing or has required active treatment
Unable to swallow capsules or tablets or malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction. If any of these conditions exist, the site should discuss with the sponsor to determine patient eligibility
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Treatment groupsSee each treatment group below.