Phase I Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a writteninformed consent form.

2. Male or female ≥ 18 years old.

3. Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12Dmutation

4. ECOG performance status of 0-1.

5. With a life expectancy of ≥3 months.

6. Have at least one measurable lesion.

7. Adequate laboratory parameters during the screening period

Exclusion Criteria:

1. Previously received KRAS G12D inhibitors

2. Priot radiotherapy within 28 days for non-thoracic radiation

3. Prior anti-tumor chemotherapy (< 6 weeks if chemotherapy including nitrosoureas ormitomycin) within 4 weeks before the study drug administration

4. Any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1or inclusion/exclusion criteria level (The investigators determined that safe andcontrollable toxicity was excluded, such as alopecia and ≤ grade 2 peripheralneuropathy ).

5. Central nervous system (CNS) metastases

6. Major surgical therapy within 28 days prior to the date of signature of informedconsent form, or expected major surgery during the study.

7. Known history of hypersensitivity to any components of HRS-4642.

8. Other factors that may affect the study results or lead to forced termination of thestudy early as judged by investigators.