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ER+, HER2- Advanced Breast CancerPhase 1/2NCT05927779

Study of TFX06 in Women With Advanced Breast Cancer.

A Phase 1/2 study testing TFX06 tablet in people with ER+, HER2- Advanced Breast Cancer and Metastatic Breast Cancer, run by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase 1/2 Dose Escalation and Expansion Study of TFX06 tablet Alone in Women with ER Positive, HER2 Negative Advanced Breast Cancer Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
TFX06 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
2 sitesChina
Study dates
17 Apr 2023to 30 Apr 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • voluntary participation in clinical trials and signature of informed consent, and be willing to comply with the requirements of the protocol Seek.
  • Age>= 18 years.
  • Postmenopausal status defined as meeting at least one of the following criteria:
  • Have undergone a bilateral oophorectomy any time in life.
  • Age ≥ 60 years.
  • Age<60 years but have natural menopause ≥ 12 months with estradiol (E2)and follicle stimulating hormone (FSH) levels in the postmenopausal range without chemical ablation(chemotherapy,toremifene, tamoxifen, or ovarian castration drugs).
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  • Premenopausal or perimenopausal concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist starting before the start of trial therapy and is planned to continue LHRH agonist during the study.
  • Subjects are willing to provide blood for Estrogen Receptor 1 (ESR1)mutation status analysis.
  • The ECOG score is 0-1 and has not deteriorated in the past 2 weeks.
  • Expected survival ≥ 3 months.
  • Histologically or cytologically confirmed breast cancer.
  • Latest primary or metastatic tumor biopsy confirmed positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor (subject to local laboratory pathological test results).
  • Prior therapy is restricted as follows:
  • No more than 2 lines of chemotherapy for advanced/metastatic breast cance or cannot tolerate standard chemotherapy (if disease progression/recurrence occurs more than 12 months after the end of previous neoadjuvant/adjuvant chemotherapy, it will not be included in line 1 chemotherapy; otherwise, it will be included in line 1 chemotherapy).
  • Prior to receiving standard endocrine therapy for at least 6 months or being unable to tolerate standard endocrine therapy (including selective estrogen receptor modulator (SERM) or aromatase inhibitors) for adjuvant therapy or advanced/metastatic diseases, and the disease progresses during endocrine therapy, Prior treatment with selective estrogen receptor degrade (SERD)is not allowed.
  • Note:For Part A, There is no limit on the number of lines of prior endocrine therapies, and multiple lines of endocrine therapy are allowed; For Part B, Prior endocrine therapy must be combination therapy or sequential therapy of CDK4/6 and AI.
  • At least one lesion (measurable and/or non-measurable, as per RECIST 1.1) Patients who planning to undergo 18F-FES PET-CT examination must have at least one measurable lesion located outside the bladder, small intestine and liver that meets RECIST v1.1 with a maximum diameter of ≥ 15mm.
  • Adequate bone marrow function (within 2 weeks (14 days) prior to study treatment) as defined below and not requiring blood transfusion or growth factor (GCSF, EPO, etc.) support
  • Hemoglobin (Hb) ≥ 90 g/L.
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L.
  • Platelet count (PLT) ≥ 75 × 10^9/L.
  • Adequate liver function is defined as follows:
  • Total bilirubin (TBIL) ≤ 1.5 × ULN； For patients with Gilbert syndrome or familial benign unconjugated hyperbilirubinemia TBIL ≤ 2.5 × ULN.
  • AST and ALT≤ 3 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver metastases are present
  • Good renal function, defined as creatinine ≤ 1.5 × ULN, or creatinine clearance rate (Ccr)>60 mL/min. The modified Cockcroft Gault formula was used to estimate creatinine clearance. Calculate Ccr: Ccr=[(140 age) × Body weight (Kg) × (Female 0.85)]/(72 × Serum creatinine), without obvious electrolyte disturbances that are not easily corrected.
  • Coagulation function: International standardized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless the subject is receiving anticoagulation therapy and the level of the patient receiving anticoagulation therapy should be within the treatment range). If the patient is receiving anticoagulation treatment, the investigator should closely monitor these laboratory test values.

Who cannot join

  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • Any unresolved toxicities from prior therapy > CTCAE Grade 1 at the time of starting Investigational Medicinal Product(IMP), with the exception of alopecia..
  • Received systemic cytotoxic chemotherapy, immunotherapy, targeted therapy anti tumor biological therapy or major surgery (Special cases: treatment with nitrourea or mitomycin C requires a 6 weeks washout period; oral fluorouracil drugs require a 2-week washout period; small molecule targeted treatment requires a 2-week washout period; treatment with traditional Chinese patent medicines and simple preparations approved by National Medical Products Administration(NMPA) requires a 2-week washout period, including: compound cantharides capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea javanica oil injection/capsule, Xiao ai ping tablet/injection, cinobufagin capsule, etc.) within 4 weeks prior to first dose of study drug.or obvious traumatic injury, wounds or fractures that have not been healed for a long time, except for pathological fractures.
  • Prior use of experimental SERD or experimental ER antagonist treatment. However, it is allowed to receive fluvastatin treatment.
  • Note: Patients planning to undergo 18F-FES PET-CT examination: If the end line treatment is a drug that acts on estrogen receptors such as fluvastatin, the 18F-FES PET-CT examination should have a 5 half life from the last medication, a time period of>6 months from the last use of fluvastatin, and a time period of ≥ 5 weeks from the last use of tamoxifen;
  • Systemic radiation therapy within 28 days or local radiation therapy within 7 days prior to first dose of study drug.
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  • Patients who are receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A within 14 day or 5 half- life (whichever is shorter) prior to first dose of study treatment.
  • Participated in other clinical trials within 30 days before the first medication or received clinical trial medication within 5 half-lives of the first medication (whichever is longer).
  • The patient is receiving other approved or experimental anticancer treatments.
  • Major surgery within 14 days before the first dose of the study drug or not recovered from serious side effects.
  • Known other malignant tumors within 3 years before enrollment (except fully treated basal or squamous cell carcinoma, non melanoma skin cancer, or radical cervical cancer.)
  • Known active central nervous system(CNS) metastasis and/or meningitis carcinomatosa:
  • subjects with treated brain metastases may be eligible if their condition is stable and they do not have the following conditions:
  • Progressive or new onset of neurological impairment, seizures, evidence of Raised intracranial pressure, vomiting, papilledema, or headache;
  • CNS tumor recurrence/progression confirmed by MRI at least 4 weeks before the first administration of this study
  • Evidence of new or enlarged brain metastases and no corticosteroids were used at least 3 days prior to the administration of the study drug.
  • Two brain MRI scans used to confirm the stability of CNS disease must be submitted to the sponsor, preferably when the subject is being screened.
  • The patient is unable to swallow the preparation, or gastrointestinal disease that may affect the absorption of the study drug (e.g., previous partial or complete gastrectomy, previous Rouxen-Y or Whipple surgery, untreated gastric or duodenal ulcer, uncontrolled/refractory nausea, vomiting, diarrhea, malabsorption syndrome, or major bowel resection).
  • The patient is currently receiving proton pump inhibitors(PPI)treatment. PPI treatment must be stopped 1 week or earlier before the first administration of TFX06.
  • According to the judgment of the sponsor/investigator, the patient currently suffers from any other serious and/or uncontrollable medical disease (e.g., severe liver damage, etc.) that is not suitable for participation in the clinical study.
  • The patient currently has a record of grade 1 (or higher) pneumonia or interstitial lung disease (ILD) (no associated pulmonary complications confirmed by baseline chest CT scans ).
  • Ophthalmological examination during the screening period confirmed clinically significant ocular lesions and were not suitable to participate in this study according to the judgment of the investigator.
  • The patient has clinically significant, uncontrolled heart disease and/or recent cardiac events, including any of the following:
  • History of angina, coronary artery bypass grafting (CABG), symptomatic pericarditis, or myocardial infarction within 12 months prior to the start of study treatment.
  • Recorded history of congestive heart failure (New York Heart Association Cardiac Function Classification III-IV).
  • Recorded cardiomyopathy.
  • Determination of a patient's left ventricular ejection fraction (LVEF)<50% using multi gated acquisition (MUGA) scans or echocardiography (ECHO).
  • Any history of arrhythmia (such as ventricular tachycardia), complete left bundle branch block, high degree atrioventricular block (such as double bundle branch block, Mobitz type II, and third degree atrioventricular block), supraventricular, nodal arrhythmia, or conduction abnormalities within the past 12 months.
  • Uncontrolled hypertension is defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg, with or without use of antihypertensive drugs. Allow initiation or adjustment of antihypertensive drug therapy before screening.
  • A family medical history of long QT syndrome, idiopathic sudden death, or congenital long QT syndrome, or any of the following:
  • Risk factors for torsade de pointe ventricular tachycardia (TdP) include uncontrolled hypokalemia or hypomagnesemia, a history of heart failure, or a history of clinically significant/symptomatic bradycardia.
  • There is a known risk of prolonging the QT interval and/or concomitant drugs that are known to cause torsade de pointe ventricular tachycardia and cannot be discontinued or replaced with safe alternative drugs.
  • Bradycardia (resting heart rate<50), measured by ECG or pulse.
  • During screening, the ECG examination was unable to determine the QTcF interval (i.e., unreadable or unreadable), or corrected for QT (QTcF)>460 ms (female) (using fridericia correction). All were determined by screening period ECG (mean of three ECGs).
  • Patient is currently receiving or has received systemic corticosteroid treatment within 2 weeks prior to the start of study treatment. or has not fully recovered from the side effects of such treatment. However, it is allowed to use corticosteroids in the following situations: single administration, local application (e.g. for rash), inhalation spray (e.g. for obstructive airway disease), eye drops or local injection (e.g. in joints).
  • Evidence of severe or uncontrolled systemic disease, including active hemorrhagic constitution.
  • History of bleeding, thrombosis, and cancer thrombus:
  • Have clinically significant bleeding symptoms or clear bleeding tendencies within 3 months prior to screen;
  • History of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within 3 months prior to screen;
  • History of arterial/venous thrombotic events that occurred within 6 months prior to screen, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, etc;
  • The presence of tumor thrombi was confirmed by imaging examination within 6 months prior to screen.
  • Known active hepatitis B or hepatitis C infection.
  • Known serious, uncontrolled infection or known infection with human immunodeficiency virus (HIV) (HIV1/2 antibody), diagnosis of acquired immunodeficiency syndrome (AIDS)，uncontrolled autoimmune diseases, or patients who have previously received a tissue/organ transplant, stem cell or bone marrow transplant.
  • Uncontrolled active bacterial, viral, fungal, rickettsia, or parasitic infections unless treated and resolved prior to study treatment.
  • Received a live viral vaccine within 30 days prior to the first administration of the study drug. Allow the use of seasonal influenza or approved COVID-19 vaccines that do not contain live viruses.
  • Other conditions that the investigator considers unsuitable for this study

Trial locations and contacts

2 sites in 1 country.

Wei Sha contact

+86 18538318618

wei.sha@vybio.com

Jia Song contact

+86 18503817651

songjia@vybio.com

China2 sites, 2 recruiting

  • The 1st Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

    zhi ye Zhang

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200120

    jian zhang, phD, 021-64175590, syner2000@163.com

    jian zhang, phD

    Not yet recruiting

Other trials in China

About this study

Official title: Phase I/II Clinical Study to Evaluate the Safety, Tolerance, Efficacy and Pharmacokinetics of TFX06 Tablet in ER Positive, HER Negative Locally Advanced or Metastatic Breast Cancer.

A Phase 1/2 Dose Escalation and Expansion Study of TFX06 tablet Alone in Women with ER Positive, HER2 Negative Advanced Breast Cancer

Read the detailed description

This is a phase Ⅰ/Ⅱ, open-label study of TFX06 tablet single agent to assess the safety and tolerability, identify an Maximum Tolerated Dose （MTD）, and/or RP2D, evaluate the pharmacokinetic（PK ）properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.

Being tested
TFX06 tablet
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TFX06 tabletDrug

    TFX06 tablet taken orally

Study groups in NCT05927779
Study groupRoleWhat they receive
Dose escalationExperimentalPart A, Dose Escalation: Patients will be assigned sequentially to escalating doses of TFX06 tablet.Safety Expansion: Additional patients will be enrolled to further evaluate the safety, tolerability and RP2D of TFX06 tablet. Part B ,Dose Expansion, A cohort of patients will be enrolled to evaluate preliminary preliminary efficacy of the TFX06 tablet in RP2D in a group of patients with at least 6 months of standard endocrine therapy prior to disease progression.
Receives: Drug: TFX06 tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase 2 Dose (RP2D)

    RP2D of TFX06 tablet when administered as monotherapy(PartA)

    Measured: The first 28 days of treatmen

  2. Disease Control Rate

    Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumor (RECIST 1.1) (Part B)

    Measured: From baseline to the date of first documentation of progression ,assessed up to 24months

Secondary outcomes (7)

  1. Incidence of Treatment-Emergent Adverse Events (AE) [Safety and Tolerability]

    AE will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0

    Measured: Up to 30 days after the end of treatment

  2. Electrocardiogram (ECG) changes [Safety and Tolerability]

    Resting 12-lead ECGs will be obtained from all subjects in order to assess any impact TFX06 may have on the QT interval as assessed by the Fridericia's Correction Formula (QTcF).

    Measured: Up to 30 days after the end of treatment

  3. Monitoring of Vital signs [Safety and Tolerability]

    Vital sign will be obtained from all subjects

    Measured: Up to 30 days after the end of treatment

  4. Monitoring of hematology and blood chemistry [Safety and Tolerability]

    Hematology and blood chemistry will be obtained from all subjects.

    Measured: Up to 30 days after the end of treatment

  5. Monitoring of coagulation function[Safety and Tolerability]

    Coagulation function will be obtained from all subjects.

    Measured: Up to 30 days after the end of treatment

  6. Monitoring of urinalysis [Safety and Tolerability]

    Urinalysis will be obtained from all subjects.

    Measured: Up to 30 days after the end of treatment

  7. Plasma concentrations of TFX06 will be assessed at predefined intervals

    Pharmacokinetics of TFX06

    Measured: Cycle0, Cycle 1(36 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start17 Apr 2023
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05927779
Sponsor's protocol ID
TFX06-001
Status last verified
Jun 2023
First submitted
3 Jun 2023
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Shenzhen YangLi Pharmaceutical Technology Co., Ltd will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP). Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TFX06 tablet in people with ER+, HER2- Advanced Breast Cancer and Metastatic Breast Cancer, run by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. 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 26 inclusion and 46 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei Sha (+86 18538318618, wei.sha@vybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase 2 Dose (RP2D) (time frame: The first 28 days of treatmen). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05927779.

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 3 Jul 2023.

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