Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations

Inclusion criteria

• Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up;
• Aged between 18-75 years, with no gender requirement;
• Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor KRAS G12D mutations; Have failed standard treatment, are intolerant to standard treatment, or have not received standard treatment.
• ECOG performance status (PS) score of 0 or 1;
• Life expectancy > 3 months;
• At least one measurable lesion per RECIST v1.1; A tumor tissue sample must be provided.
• Adequate organ function

Exclusion criteria

• Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in the inclusion/exclusion criteria;
• Presence of central nervous system (CNS) metastases;
• Participants with gastrointestinal diseases that affect drug administration/absorption
• Participants who have undergone major surgery other than diagnosis or biopsy within 28 days before the first dose, or are expected to undergo major surgery during the study period;
• Presence of serious pulmonary diseases
• Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated;
• Active or persistent gastrointestinal bleeding within 6 months prior to screening;
• History of allogeneic bone marrow or solid organ transplantation;
• History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;
• Positive human immunodeficiency virus (HIV) (HIV1/2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA);
• Known history of hypersensitivity to any component of the drug product to be used in the study;