A Phase 1/2, Study of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation

Exclusion Criteria

• •Patients are excluded from the study if any of the following criteria apply:
• •The patient will be excluded from participating in the trial if meet any of the following:
• •1. Patient has disease that is suitable for therapy administered with curative intent.
• •2. Subjects who have received prior treatment with KRAS G12C targeted agents.
• •3. Subjects who have received 4 or more lines of prior therapy.
• •The patient will be excluded from participating in the trial if meet any of the following:
• •1. Patient has disease that is suitable for therapy administered with curative intent.
• •2. Subjects who have received prior treatment with KRAS G12C targeted agents or pan-KRAS inhibitors.
• •3. Subjects who have received 4 or more lines of prior therapy.
• •4. Central nervous system (CNS) involvement with tumor.
• •5. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
• •6. Unresolved toxicities from prior therapy, defined as having not resolved to NCI CTCAE v.5.0 Grade 0 or 1, with exception of endocrinopathies from prior therapy and successfully treated (such as hypothyroidism), as well as alopecia and vitiligo.
• •7. Patient has an active infection requiring systemic therapy.
• •8. Patients who have known active HIV, Hepatitis or Hepatitis or active COVID-19 infection. (Patients who have been vaccinated against Hepatitis B and who are positive only for the Hepatitis B surface antibody are permitted to participate in the study). Subjects who are positive for HIV or hepatitis B or C virus must be tested for and have an undetectable viral load.
• •9. Patients with unstable/inadequate cardiac function:
• •New York Heart Association Class 3 or 4 congestive heart failure, Uncontrolled hypertension, Acute coronary syndrome within 6 months, Clinically significant cardiac arrhythmia, Mean QTC interval corrected for heart rate \>500ms.
• •10. Patient has a history of interstitial lung disease.
• •11. Current active additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• •12. Participation in another clinical trial of an investigational agent within 30 days of screening.
• •13. Patient has known psychiatric, substance abuse or other disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the investigator.
• •14. Patients who are pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.