Phase 1 Study of HS-10541 as Monotherapy or in Combination With Other Anti-cancer Therapies in Patients With KRAS G12C Mutation Advanced Solid Tumors.

Inclusion criteria

• Voluntary participation and written informed consent..
• Aged 18 years or older (≥18 years), of any gender.
• Histologically or cytologically confirmed advanced solid tumor.
• At least one measurable lesion according to RECIST v1.1.
• ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose.
• With a life expectancy > 12 weeks.
• Adequate bone marrow reserve and organ function.
• Female participants of childbearing potential and non-sterilized male participants must agree to use highly effective contraceptive measures from the time of signing the ICF until 6 months after the last dose.
• Female participants of childbearing potential must be non-lactating; all female participants must have a negative pregnancy test prior to the first dose.

Exclusion criteria

• Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
• Presence of symptomatic brain metastases, leptomeningeal/brainstem involvement, history of intracranial hemorrhage or intraspinal hemorrhage, or spinal cord compression.
• Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
• History of a second primary malignancy
• Severe, uncontrolled, or active cardiovascular or cerebrovascular diseases, or severe cardiac examination abnormalities.
• Severe or poorly controlled diabetes mellitus or hypertension.
• Known active infectious diseases.
• Clinically significant gastrointestinal dysfunction.
• Gastrointestinal obstruction or perforation occured.
• Interstitial lung disease (ILD).
• Participants with known hypersensitivity or contraindications to any active or inactive ingredients of the study drug, chemically similar drugs, or drugs of the same class.
• Other inappropriate situation considered by the investigator.