Actively Recruiting
A Study of TYK-00540 in Adult Patients With Solid Tumors
Led by TYK Medicines, Inc · Updated on 2024-02-07
156
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the safety and tolerability of TYK-00540, with dose-escalation stage and dose-expansion stage.
CONDITIONS
Official Title
A Study of TYK-00540 in Adult Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older.
- Locally advanced or metastatic solid tumors confirmed by histology or cytology.
- For single-agent escalation: tumors without standard of care (SOC), failed or intolerant to SOC.
- For single-agent expansion phase: platinum-resistant high-grade serous ovarian cancer (female only) or triple-negative breast cancer with at least two prior SOC regimens.
- For combination-agent escalation and expansion: ER+/HER2- breast cancer relapsed or progressed after CDK4/6 inhibitors with limited prior chemotherapy.
- Measurable or evaluable lesions at baseline (RECIST 1.1 required in expansion phase).
- ECOG performance status of 0 to 1 without recent deterioration.
- Life expectancy of at least 3 months.
- Adequate organ function including liver enzymes, bilirubin, blood counts, renal function, coagulation, and heart ejection fraction.
- Ability and willingness to provide informed consent.
- Willingness to use effective birth control during treatment and for 6 months after last dose.
You will not qualify if you...
- Allergy to TYK-00540 or excipients (and fulvestrant for combination phases).
- Recent systemic anti-tumor therapy within specified washout periods before first dose.
- Major surgery within 4 weeks before starting treatment.
- Use of proton pump inhibitors within 7 days before first dose or needing them during the study.
- Medications prolonging QTc interval or causing ventricular tachycardia during treatment.
- Participation in other clinical trials within 28 days before first dose.
- Prior allogeneic bone marrow transplant.
- History or current other malignancies except certain cured or stable cancers.
- Unresolved toxicities from prior treatments above grade 1 except alopecia or neuropathy.
- Active or uncontrolled central nervous system tumors or metastases requiring steroids.
- Symptoms of spinal cord compression.
- Uncontrolled effusions in chest, abdomen, pelvis, or pericardium.
- Significant ECG abnormalities affecting safety.
- Recent serious cardiac events or arrhythmias within 6 months.
- Other unstable or serious medical conditions including uncontrolled hypertension or diabetes.
- Active infections including HIV, hepatitis B or C except asymptomatic carriers.
- History or active interstitial lung disease or pneumonitis requiring treatment.
- Significant gastrointestinal conditions affecting drug absorption.
- Clinically significant hypercoagulability.
- Pregnant or lactating women.
- Any condition deemed unsuitable for study participation by investigator judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui Provincial Hospital
Hefei, China
Actively Recruiting
Research Team
J
Jian Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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