HR-positive, HER2-negative Advanced Breast CancerPhase 1/2NCT06950086
Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors
A Phase 1/2 study testing TYK-00540 in people with HR-positive, HER2-negative Advanced Breast Cancer, run by TYK Medicines, Inc at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR-positive, HER2-negative Advanced Breast Cancer
- What is being tested?
- TYK-00540
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 2 Jan 2024to Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 only.
- Other cohorts: No gender restriction.
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- Monotherapy Dose-Escalation Phase:
- 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 Dose-Expansion Phase:
- Cohort A-1: Histologically or cytologically confirmed advanced platinum-resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer:
- Platinum resistance defined as: Disease recurrence/progression <6 months after completion of prior platinum-based chemotherapy (≥4 cycles) or progression during initial/recurrent treatment.
- Disease recurrence/progression requires:
- 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 documented instance).
- Combination Dose-Selection Phase:
- HR+/HER2- advanced breast cancer with confirmed resistance to CDK4/6 inhibitors (≥1 documented instance).
- Combination Dose-Expansion Phase:
- Cohort B-1: HR+/HER2- advanced breast cancer with prior endocrine therapy resistance and either:
- No prior CDK4/6 inhibitor treatment; OR
- CDK4/6 inhibitor-treated in the adjuvant setting with recurrence >1 year after completion (no confirmed resistance).
- Cohort B-2: HR+/HER2- advanced breast cancer with progression during/after endocrine + CDK4/6 inhibitor therapy:
- For adjuvant CDK4/6 inhibitor resistance: Recurrence during or ≤1 year after treatment;
- ≥1 documented CDK4/6 inhibitor resistance.
- Note for Cohorts A-2, Combination Dose-Selection, and Combination Expansion Phases:
- 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 formula, Appendix III).
- Hematology:Platelets ≥90×10^9/L, ANC ≥1.5×10^9/L, Hb ≥90 g/L (without transfusion/G-CSF within 2 weeks).
- Cardiac:LVEF ≥50% (echocardiogram), QTcF <470 ms. Coagulation:INR ≤1.5, APTT ≤1.5×ULN (without anticoagulation).
- 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 contraception/abstinence during the same period.For fulvestrant combination: Contraception until 1 year after last dose.
- Voluntary signed ICF (or by legal guardian) and willingness to comply with study procedures.
Who cannot join
- 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 fluorouracil-based oral agents within 14 days prior to first dose.
- Nitrosoureas or mitomycin within 6 weeks prior to first dose. Anticancer herbal medicine or traditional Chinese medicine within 7 days prior to first dose.
- Local radiotherapy (e.g., thoracic/rib) or palliative radiotherapy for bone metastases within 7 days prior to first dose.
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- Major surgery (excluding minor procedures, e.g., appendectomy, tumor biopsy) within 4 weeks prior to first dose.
- Proton pump inhibitor (PPI) use 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 (Appendix V).
- Participation in other interventional clinical trials within 28 days prior to first dose (non-interventional trials excluded).
- Prior allogeneic bone marrow transplantation. For Combination Phases: prior use of fulvestrant, other SERDs, or SERCAs.
- 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 disease-free survival >3 years.
- 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 treatment ≥14 days, radiologically confirmed stability at screening).
- 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 bradycardia/tachycardia).
- 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, third-degree AV block), unstable angina, coronary/peripheral bypass, symptomatic CHF (NYHA Class III/IV), stroke, TIA, symptomatic pulmonary embolism, or clinically significant thromboembolism.Persistent NCI CTCAE ≥Grade 2 arrhythmia, atrial fibrillation (asymptomatic atrial fibrillation ≥Grade 2).
- Exception: Patients with cardiac pacemakers/devices and QTcF >470 ms may be eligible after discussion with the medical monitor.
- 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 disease, severe psychiatric/neurological/cardiovascular/respiratory disorders.
- 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 chronic HBV/HCV carriers.
- 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 conditions).
- 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.).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
JIAN ZHANG, Doctor, CN-021-64175590, syner2000@163.com
About this study
Official title: A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of the CDK2/4/6 Inhibitor TYK-00540 Tablets in Patients With Advanced Solid Tumors
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.
Read the detailed description
This is an open-label, multi-center, dose-escalation and expansion phase I/II study to evaluate dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) in subjects with locally advanced or metastatic solid tumors.
To investigate the pharmacokinetic profile of TYK-00540 and its metabolites after single then multiple doses of TYK-00540 administered orally once daily. To assess preliminary effectiveness. To evaluate the efficacy of TYK-00540 combined with fulvestrant in subjects with ER+/HER2- breast cancer who have relapsed or progressed after treatment with CDK4/6 inhibitors
- Being tested
- TYK-00540
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TYK-00540Drug
Increased dose cohorts from low to MTD (5mg Cohort 1;10 mg Cohort 2; 20 mg Cohort 3; 30 mg Cohort 4;40 mg Cohort 5) decreased dose cohorts for the combination (TYK-00540 30 mg+Fulvestrant Cohort 1;TYK-00540 20mg +Fulvestrant)
| Study group | Role | What they receive |
|---|---|---|
| TYK-00540±Fulvestrant | Experimental | TYK-00540• Find the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D) of TYK-00540, given orally. • Increased dose cohorts from low dose to MTD, starting at 5mg twicely.
fulvestrant: is in the form of a syringe containing 5ml of an injection solution of 250mg of fulvestrant for injection. The recommended dose is every 28 days, once at a dose of 500mg, and on the 15th day after the initial injection, a loading dose of fulvestrant 500mg id added. Receives: Drug: TYK-00540 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE
Measured: Within 31 days of the first dose
Recommended dose for combination-agent escalation and single-agent expansion (RDE)
To determine the recommended dose for combination-agent escalation and single-agent expansion agent expansion.
Measured: 1 year
Adverse events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: From Baseline up to 28 days after the end of the treatment
Objective response rate (ORR)
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: At least 24 weeks
Secondary outcomes (4)
The time to the peak concentration (Tmax)
Tmax is defined as the time of maximum concentration of the drug in blood observed after a drug dose administration.
Measured: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Maximum plasma concentration (Cmax)
Cmax is the maximum (or peak) plasma concentration that the drug achieves in blood after the drug has been administered.
Measured: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Minimum plasma concentration (Cmin)
Cmin is the minimum plasma concentration that the drug achieves in blood after the drug has been administered.
Measured: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Disease Control Rate (DCR)
DCR is defined as the proportion of patients with a best overall response of complete response (CR) , partial response (PR) or Stable disease (SD) ≥6 weeks during the study treatment
Measured: At least 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start2 Jan 2024
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR-positive, HER2-negative Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TYK Medicines, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950086
- Sponsor's protocol ID
- TYKM5807101
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of the CDK2/4/6 Inhibitor TYK-00540 Tablets in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06950086
- Acronym / sponsor ID
- TYKM5807101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- TYK Medicines, IncIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, multi-center, dose-escalation and expansion phase I/II study to evaluate dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) in subjects with locally advanced or metastatic solid tumors.
To investigate the pharmacokinetic profile of TYK-00540 and its metabolites after single then multiple doses of TYK-00540 administered orally once daily. To assess preliminary effectiveness. To evaluate the efficacy of TYK-00540 combined with fulvestrant in subjects with ER+/HER2- breast cancer who have relapsed or progressed after treatment with CDK4/6 inhibitors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TYK-00540±Fulvestrant | Experimental | Drug: TYK-00540TYK-00540• Find the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D) of TYK-00540, given orally. • Increased dose cohorts from low dose to MTD, starting at 5mg twicely. fulvestrant: is in the form of a syringe containing 5ml of an injection solution of 250mg of fulvestrant for injection. The recommended dose is every 28 days, once at a dose of 500mg, and on the 15th day after the initial injection, a loading dose of fulvestrant 500mg id added. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (51 listed)
- Age ≥18 years, gender requirements:
- Monotherapy dose-escalation phase: No gender restriction.
- Combination dose-selection phase: No gender restriction.
- Cohort A-1: Females only.
- Other cohorts: No gender restriction.
Key exclusion criteria (27 listed)
- 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 fluorouracil-based oral agents within 14 days prior to first dose.
- Nitrosoureas or mitomycin within 6 weeks prior to first dose. Anticancer herbal medicine or traditional Chinese medicine within 7 days prior to first dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TYK-00540Increased dose cohorts from low to MTD (5mg Cohort 1;10 mg Cohort 2; 20 mg Cohort 3; 30 mg Cohort 4;40 mg Cohort 5) decreased dose cohorts for the combination (TYK-00540 30 mg+Fulvestrant Cohort 1;TYK-00540 20mg +Fulvestrant) | Drug | TYK-00540±Fulvestrant |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: Within 31 days of the first dose
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE
Recommended dose for combination-agent escalation and single-agent expansion (RDE)
Time frame: 1 year
To determine the recommended dose for combination-agent escalation and single-agent expansion agent expansion.
Adverse events (AEs)
Time frame: From Baseline up to 28 days after the end of the treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Objective response rate (ORR)
Time frame: At least 24 weeks
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
4 secondary outcomes
The time to the peak concentration (Tmax)
Time frame: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Maximum plasma concentration (Cmax)
Time frame: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Minimum plasma concentration (Cmin)
Time frame: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Disease Control Rate (DCR)
Time frame: At least 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TYK-00540 in people with HR-positive, HER2-negative Advanced Breast Cancer, run by TYK Medicines, Inc at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 51 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang (021-64175590, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: Within 31 days of the first dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.