A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation

Exclusion Criteria

• •At least 1 measurable target lesion that meets the definition of RECIST v1.1
• •ECOG Performance Status of 0 or 1
• •Demonstrate adequate organ function
• •Expected survival time \> 3 months in the opinion of the investigator
• •Must be able to swallow oral medications and must not have gastrointestinal abnormalities that significantly affect drug absorption
• •History of another concurrent malignancy within 3 years prior to study entry, unless the malignancy was treated with curative intent and the likelihood of relapse is \<5% in 2 years Note: Subjects with a history of squamous or basal cell carcinoma of the skin or carcinoma in the situ of the cervix may be enrolled
• •Untreated or symptomatic central nervous system (CNS) metastases Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroids for at least 4 weeks
• •Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first dose of HBI-2438; or the presence of unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher
• •Any unresolved Grade 2 or greater toxicity from previous anti-cancer therapy, except alopecia, within 4 weeks of first study treatment administration
• •Active autoimmune diseases or history of autoimmune diseases that may relapse
• •Pregnant or nursing
• •Prior treatment with any KRAS G12C inhibitors
• •Any condition that required systemic treatment with either corticosteroids (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the first study treatment administration
• •Treatment with other investigational drugs/devices within 4 weeks prior to first study treatment administration