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 range18 Years
SexALL
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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:
✕. Unstable brain metastases,such as:
✕. 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.
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
✕. 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.