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.

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10541 as Monotherapy or in Combination With Other Anti-cancer Therapies in Participants With KRAS G12C Mutation Advanced Solid Tumors.

This is a multicenter, open-label phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HS-10541 as monotherapy or in combination with other anti-cancer therapies in participants with KRAS G12C mutation advanced solid tumors.

Inclusion Criteria:

1. Voluntary participation and written informed consent..
2. Aged 18 years or older (≥18 years), of any gender.
3. Histologically or cytologically confirmed advanced solid tumor.
4. At least one measurable lesion according to RECIST v1.1.
5. ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose.
6. With a life expectancy > 12 weeks.
7. Adequate bone marrow reserve and organ function.
8. 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.
9. 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:

1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
2. Presence of symptomatic brain metastases, leptomeningeal/brainstem involvement, history of intracranial hemorrhage or intraspinal hemorrhage, or spinal cord compression.
3. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
4. History of a second primary malignancy
5. Severe, uncontrolled, or active cardiovascular or cerebrovascular diseases, or severe cardiac examination abnormalities.
6. Severe or poorly controlled diabetes mellitus or hypertension.
7. Known active infectious diseases.
8. Clinically significant gastrointestinal dysfunction.
9. Gastrointestinal obstruction or perforation occured.
10. Interstitial lung disease (ILD).
11. 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.
12. Other inappropriate situation considered by the investigator.