Actively Recruiting
Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors
Led by TYK Medicines, Inc · Updated on 2025-04-29
180
Participants Needed
2
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.
CONDITIONS
Official Title
Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Locally advanced or metastatic solid tumors with no standard treatment available, or failure/intolerance/refusal of standard treatment
- Histologically or cytologically confirmed advanced platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with defined platinum resistance
- HR+/HER2- advanced breast cancer with confirmed resistance to CDK4/6 inhibitors or prior endocrine therapy resistance as specified
- For female patients in combination phases, meet at least one condition indicating postmenopausal status or use LHRH agonists/antagonists
- Presence of extracranial evaluable or measurable lesions as applicable
- ECOG performance status 0-1 without deterioration within 2 weeks prior to first dose
- Life expectancy of at least 3 months
- Adequate organ function including liver, kidney, hematology, cardiac, and coagulation parameters
- Agreement to use effective contraception or abstinence during and after the study as specified
- Voluntary signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Known hypersensitivity to TYK-00540 components or contraindication to fulvestrant
- Recent systemic anticancer therapies within specified timeframes prior to first dose
- Use of proton pump inhibitors within 7 days prior to first dose or during the study
- Concurrent use of medications known to prolong QTc interval or induce torsades de pointes
- Participation in other interventional clinical trials within 28 days prior to first dose
- Prior allogeneic bone marrow transplantation; prior use of fulvestrant, other SERDs, or SERCAs in combination phases
- History of other malignancies except certain cured cancers or those with disease-free survival over 3 years
- Residual toxicity from prior therapy greater than grade 1 except alopecia or platinum-related neuropathy
- Central nervous system disease including certain tumors or metastases unless stable and asymptomatic
- Spinal cord compression caused by tumor
- Visceral crisis
- Uncontrolled pleural effusion, ascites, or pericardial effusion requiring intervention
- Significant ECG abnormalities at baseline
- Cardiovascular events within 6 months including myocardial infarction, unstable angina, stroke, and others
- Unstable or uncontrolled medical conditions affecting safety or compliance including uncontrolled hypertension or diabetes
- Active or uncontrolled infections including certain viral infections except asymptomatic carriers
- Lung diseases such as radiation pneumonitis requiring steroids or interstitial lung disease
- Gastrointestinal disorders affecting drug absorption
- Recent thromboembolic events within 6 months
- Pregnancy or lactation
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Jian Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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