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New treatment option for HR-positive, HER2-negative Advanced Breast Cancer
Official title Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06950086
What this study is testing
What is TYK-00540?
TYK-00540 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hr-positive, her2-negative advanced breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years, gender requirements: Monotherapy dose-escalation phase: No gender restriction. Combination dose-selection phase: No gender...
- Histologically or cytologically confirmed locally advanced/metastatic solid tumors with no standard treatment available, failure of/intolerance to...
- Objective radiographic progression; OR
- Persistent CA125 elevation (confirmed after 1 week) with clinical symptoms or signs of progression.
- 3 prior lines of chemotherapy for recurrent/metastatic disease, with ≤1 systemic therapy after platinum resistance. Cohort A-2: HR+/HER2- advanced...
You likely can't join if
- Known hypersensitivity to any excipient of TYK-00540 or contraindication to fulvestrant (for Combination Dose-Selection and Combination Expansion...
- Prior/concurrent therapies: Systemic anticancer therapies within 28 days prior to first dose: chemotherapy, large-molecule targeted therapy...
- History of other malignancies, except:Cured basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma...
- Residual toxicity from prior therapy \>Grade 1 (except alopecia or platinum-related neuropathy).
- Central nervous system (CNS) disease:Primary CNS tumors, CNS metastases with prior local treatment failure, or newly diagnosed CNS...
- Spinal cord compression caused by tumor.
See the full eligibility criteria
Who can join
- Age ≥18 years, gender requirements: Monotherapy dose-escalation phase: No gender restriction. Combination dose-selection phase: No gender restriction. Monotherapy and combination expansion phases: Cohort A-1: Females...
- Histologically or cytologically confirmed locally advanced/metastatic solid tumors with no standard treatment available, failure of/intolerance to standard treatment, or refusal of standard treatment. Monotherapy...
- Objective radiographic progression; OR
- Persistent CA125 elevation (confirmed after 1 week) with clinical symptoms or signs of progression.
- 3 prior lines of chemotherapy for recurrent/metastatic disease, with ≤1 systemic therapy after platinum resistance. Cohort A-2: HR+/HER2- advanced breast cancer with confirmed resistance to CDK4/6 inhibitors (≥1...
- 2 prior endocrine therapy regimens for recurrent/metastatic disease (adjuvant endocrine therapy leading to recurrence within 1 month of completion counts as 1 regimen).
- 1 prior chemotherapy or ADC regimen for recurrent/metastatic disease. Prior CDK4/6 inhibitor use:
- Duration ≥6 months;
- Adjuvant CDK4/6 inhibitor use with progression \>1 year after completion does not count as resistance;
- Switching CDK4/6 inhibitors due to intolerance is permitted.
- For female patients in Combination Phases: Meet ≥1 of the following:
- Bilateral oophorectomy;
- Age ≥60 years;
- Age \<60 years with natural menopause ≥12 months (without chemotherapy, tamoxifen, toremifene, or ovarian suppression in the past year), confirmed by postmenopausal FSH and estradiol levels;
- Age \<60 years on tamoxifen/toremifene with postmenopausal FSH and estradiol levels. Non-postmenopausal patients must use LHRH agonists/antagonists throughout the study.
- Baseline Lesions: Monotherapy dose-escalation: Extracranial evaluable/measurable lesions. Combination phases: Extracranial measurable lesions (RECIST 1.1).
- ECOG performance status 0-1, no deterioration within 2 weeks prior to first dose (Appendix II).
- Life expectancy ≥3 months.
- Adequate Organ Function: Liver:TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN (≤5×ULN for liver metastases; ≤3×ULN for combination with fulvestrant). Kidney:Serum creatinine ≤1.5×ULN, creatinine clearance ≥50 mL/min (Cockcroft-Gault...
- Contraception:Females of childbearing potential: Negative pregnancy test and commitment to highly effective contraception/abstinence from screening until 6 months post-treatment (Appendix IV).Males: Commitment to...
- Voluntary signed ICF (or by legal guardian) and willingness to comply with study procedures.
What rules you out
- Known hypersensitivity to any excipient of TYK-00540 or contraindication to fulvestrant (for Combination Dose-Selection and Combination Expansion Phases).
- Prior/concurrent therapies: Systemic anticancer therapies within 28 days prior to first dose: chemotherapy, large-molecule targeted therapy, immunotherapy. Endocrine therapy, small-molecule targeted therapy, or...
- History of other malignancies, except:Cured basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma, ductal carcinoma in situ of the breast, or malignancies with...
- Residual toxicity from prior therapy \>Grade 1 (except alopecia or platinum-related neuropathy).
- Central nervous system (CNS) disease:Primary CNS tumors, CNS metastases with prior local treatment failure, or newly diagnosed CNS metastases.Exception: Asymptomatic, stable CNS metastases (no steroids/CNS-specific...
- Spinal cord compression caused by tumor.
- Visceral crisis.
- Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring repeated drainage/medical intervention (within 14 days prior to first dose).
- Clinically significant ECG abnormalities at baseline (e.g., QTc ≥470 ms, complete LBBB, acute/indeterminate-age myocardial infarction, ST-T changes suggesting ischemia, second-/third-degree AV block, severe...
- Cardiovascular events within 6 months:Myocardial infarction, long QT syndrome, torsades de pointes, arrhythmias (sustained ventricular tachycardia/fibrillation), severe conduction defects (e.g., bifascicular block...
- Unstable or uncontrolled medical conditions affecting safety/compliance, including:Uncontrolled hypertension (systolic BP \>160 mmHg and/or diastolic BP \>100 mmHg).Uncontrolled diabetes, active bleeding, ocular...
- Active/uncontrolled infections or immunodeficiencies:Active HBV (HBsAg-positive with HBV DNA ≥2000 copies/mL [or 500 IU/mL]).Active HCV (HCV antibody-positive with HCV RNA-positive).HIV-positive.Exception: Asymptomatic...
- Lung disease:Radiation pneumonitis requiring steroids, interstitial lung disease (ILD)/pneumonitis (active or drug-induced), acute/progressive pulmonary fibrosis, or high-risk factors for ILD per investigator judgment.
- Clinically significant gastrointestinal disorders affecting drug absorption (e.g., dysphagia, uncontrolled vomiting, active ulcers, inflammatory bowel disease, chronic diarrhea, bowel obstruction, chronic PPI-dependent...
- Hypercoagulability with thromboembolic events within 6 months (e.g., stroke, DVT, pulmonary embolism).
- Pregnancy, lactation.
- The investigator concluded that the patient was not suitable to participate in the study (such as not conforming to the most beneficial treatment for the patient, patient compliance, etc.).
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.