Tests TYK-01054 capsules in adults with advanced solid tumors
Tests TYK-01054 capsules in adults with advanced solid tumors, including mesothelioma.
Plain-language title generated from the registry record
Registry title: Study of TYK-01054 Capsules in Patients With Advanced Solid Tumors
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- Shanghai Chest HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- TYK Medicines, Inc
- Trial code
- NCT07282873
- Record updated
- 22 December 2025
- Original description
This study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of the TEAD inhibitor TYK-01054 capsules in patients with locally advanced or metastatic advanced solid tumorsRead full original descriptionShow less
A Phase I/II, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of the TEAD Inhibitor TYK-01054 Capsules in Patients With Locally Advanced or Metastatic Advanced Solid Tumors
This study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of the TEAD inhibitor TYK-01054 capsules in patients with locally advanced or metastatic advanced solid tumors
Inclusion: 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.
Exclusion: Patients who have previously received a TEAD inhibitor; 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; 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.