Study of TYK-01054 Capsules in Patients With Advanced Solid Tumors (NCT07282873) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Study of TYK-01054 Capsules in Patients With Advanced Solid Tumors
China219 participantsStarted 2026-01-01
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. History of other malignancy, except for:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Limiting Toxicity
Timeframe: Up to approximately 28 days
2
Maximum tolerated dose（MTD）
Timeframe: Through the Dose Escalation phase, approximately 12 months
3
Number of participants who experience one or more adverse events (AEs)
Timeframe: From Baseline up to 28 days after the end of the treatment
4
Recommended Dose for Expansion(RDE)
Timeframe: Through the Dose Escalation Phase, approximately 24 months
5
Recommended Phase 2 Dose（RP2D）
Timeframe: Within 28 days of the last patient dosed in the Dose Optimization stage
. Presence of pleural effusion, pericardial effusion, or ascites that, in the investigator's judgment, cannot be stably controlled by repeated drainage or other methods.
. 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.
. Patients who have previously received a TEAD inhibitor.