Study of TFX06 in Women With Advanced Breast Cancer.

NCT05927779 | Unknown Phase 1

• 1 other identifier: TFX06-001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

ER+, HER2- Advanced Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Recommended phase 2 Dose (RP2D)

  RP2D of TFX06 tablet when administered as monotherapy(PartA)

  The first 28 days of treatmen

• Disease Control Rate

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

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

Secondary Outcomes (7)

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

  Up to 30 days after the end of treatment

• Electrocardiogram (ECG) changes [Safety and Tolerability]

  Up to 30 days after the end of treatment

• Monitoring of Vital signs [Safety and Tolerability]

  Up to 30 days after the end of treatment

• Monitoring of hematology and blood chemistry [Safety and Tolerability]

  Up to 30 days after the end of treatment

• Monitoring of coagulation function[Safety and Tolerability]

  Up to 30 days after the end of treatment

Study Arms (1)

Dose escalation

EXPERIMENTAL

Part 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.

Drug: TFX06 tablet

Interventions

TFX06 tablet DRUG

TFX06 tablet taken orally

Dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Zhejiang Yangli Pharmaceutical Technology Co., Ltd.: lead

Study Sites (2)

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

Luoyang, Henan, 471003, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200120, China

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jian Zhang

  Fudan University Affiliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Sha

CONTACT

+86 18538318618; wei.sha@vybio.com

Jia Song

CONTACT

+86 18503817651; songjia@vybio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2023
• First Posted: July 3, 2023
• Study Start: April 17, 2023
• Primary Completion: December 30, 2024
• Study Completion: April 30, 2025
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)