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

Prior treatment

• Patients who have previously received a TEAD inhibitor.

Other illness

• 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.
• 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).
• Clinically significant renal disease.
• Clinically significant cardiovascular disease, including but not limited to myocardial infarction, unstable angina, congestive heart failure (NYHA Class ≥ II), or uncontrolled arrhythmias.
• 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.
• Known or suspected hypersensitivity to TYK-01054 or any of its excipients, or to compounds of similar chemical class.

Other

• Presence of pleural effusion, pericardial effusion, or ascites that, in the investigator's judgment, cannot be stably controlled by repeated drainage or other methods.
• Women who are pregnant or breastfeeding.

• Male or female subjects ≥18 years old
• 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.
• 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.
• Patients should have at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1.
• Adequate organ function, including hepatic, renal, cardiovascular, astrointestinal,respiratory, and hematopoietic systems.
• ECOG 0-1，
• Life expectancy of \>3 months.
• Willing and able to comply with all aspects of the protocol.