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

Inclusion criteria

• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
• Male or female ≥ 18 years old.
• Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12D mutation
• ECOG performance status of 0-1.
• With a life expectancy of ≥3 months.
• Have at least one measurable lesion.
• Adequate laboratory parameters during the screening period

Exclusion criteria

• Previously received KRAS G12D inhibitors
• Priot radiotherapy within 28 days for non-thoracic radiation
• Prior anti-tumor chemotherapy (< 6 weeks if chemotherapy including nitrosoureas or mitomycin) within 4 weeks before the study drug administration
• Any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or inclusion/exclusion criteria level (The investigators determined that safe and controllable toxicity was excluded, such as alopecia and ≤ grade 2 peripheral neuropathy ).
• Central nervous system (CNS) metastases
• Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
• Known history of hypersensitivity to any components of HRS-4642.
• Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.