Study of TYK-01054 Capsules in Patients With Advanced Solid Tumors

Inclusion Criteria:

1. Male or female subjects ≥18 years old
2. Histologically or cytologically confirmed incurable, locally advanced or metastatic advanced solid tumors. All participants are required to provide results of Hippo signaling pathway gene testing; however, this requirement is not a mandatory inclusion criterion for Dose Escalation (Part A) and EHE patients.
3. Advanced solid tumors must have progressed after receiving at least one standard first-line anti-tumor therapy, OR demonstrate intolerance to standard therapy, OR Lack of standard treatment.
4. Patients should have at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1.
5. Adequate organ function, including hepatic, renal, cardiovascular, astrointestinal,respiratory, and hematopoietic systems.
6. ECOG 0-1，
7. Life expectancy of \>3 months.
8. Willing and able to comply with all aspects of the protocol.

Exclusion Criteria:

1. History of other malignancy, except for:

   Non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma) that is non-invasive and has been effectively controlled with no recurrence or metastasis for 5 years, Papillary thyroid carcinoma, Carcinoma in situ of the cervix, Ductal carcinoma in situ of the breast.
2. Unstable brain metastases,such as:

   Patients requiring urgent neurosurgical intervention for CNS complications, Presence of symptomatic spinal cord compression due to tumor, Presence of leptomeningeal disease (carcinomatous meningitis).
3. Presence of pleural effusion, pericardial effusion, or ascites that, in the investigator's judgment, cannot be stably controlled by repeated drainage or other methods.
4. Clinically significant renal disease.
5. Clinically significant cardiovascular disease, including but not limited to myocardial infarction, unstable angina, congestive heart failure (NYHA Class ≥ II), or uncontrolled arrhythmias.
6. Patients with uncontrolled infectious diseases, such as immunodeficiency disorders (e.g., HIV) or active hepatitis B or C infection; chronic hepatitis B or C carriers without symptoms are excluded from this criterion.
7. Known or suspected hypersensitivity to TYK-01054 or any of its excipients, or to compounds of similar chemical class.
8. Patients who have previously received a TEAD inhibitor.
9. Women who are pregnant or breastfeeding.