Status:
UNKNOWN
A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer
Lead Sponsor:
Genor Biopharma Co., Ltd.
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
GB491-005 is a multicenter, open-label, phase Ib Clinical Trial study to evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GB491 in combi...
Eligibility Criteria
Inclusion
- Females of 18 years of age or older at study screening
- Histologically or cytologically confirmed locally advanced or advanced metastatic breast cancer that is not amenable to curative surgical resection or radiation therapy
- The subject has been diagnosed with ER-positive breast cancer in the local laboratory
- The subject has HER2-negative breast cancer in the local laboratory
- Menopausal status is not limited (including Premenopausal/perimenopausal/postmenopausal state)
- No previous systemic anti-tumor treatment for locally advanced or metastatic breast cancer;
- According to RECIST V1.1, the patient has at least one measurable lesion that has not been irradiated by radiotherapy and can be evaluated by CT/MRI; If only bone metastases are present, there must be at least one osteolytic bone lesion that can be evaluated by CT/MRI
- ECOG performance status of 0 or 1
- Adequate organ and marrow function.
- The subject of childbearing potential must use one highly effective birth control method from the total duration of the study and 6 months after the last dose of study intervention.
- Provide informed consent
Exclusion
- Previous treatment with CDK4/6 inhibitors
- Subjects with known hypersensitivity to any component of GB491 or Letrozole
- Patients with disease progression or recurrence during or within 1 year after completion of previous endocrine neoadjuvant or adjuvant therapy
- Known active, uncontrolled, or symptomatic central nervous system metastasis, carcinomatous meningitis, or clinically manifested leptomeningeal disease, cerebral edema, spinal compression or/and tumor progressive growth
- Visceral crisis
- Patients with skin lesion only and radiographically non-measurable at baseline
- Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia
- Major surgical procedure within 4 weeks of the first dose of study treatment or an anticipated need for major surgery, chemotherapy, radiotherapy, any other investigational drug or other anti-cancer therapy during the study
- Patients who have been on bisphosphonates and denosumab therapy at a stable dose for less than 14 days prior to randomization
- Patients who have received limited field radiotherapy in 2 weeks or extended field radiotherapy in 4 weeks before randomization or radiation with more than 30% of the bone marrow
- Subjects use drugs or fruits containing strong inducers or inhibitors of CYP3A4/5, or drugs with narrow therapeutic window that are mainly metabolized by CYP3A4/5 in 14 days before randomization
- Patients with long-term systematic use of corticosteroids
- Any severe and/or uncontrollable medical conditions
- Patients with severely impaired lung function
- Known history of HIV infection or history of HIV seropositivity
- Resting QTcF \> 480 msec or there is a medical history of QTcF prolongation
- Subjects have significant hepatic disease
- Coagulation abnormalities
- Refractory nausea and vomiting, inability to swallow the formulated product, or other disease or clinical status would preclude adequate absorption, distribution, metabolism, or excretion of GB491
- Previous allogeneic bone marrow transplant
- Inflammatory breast cancer;
- Subjects with a history of other primary malignancies, except for non-melanoma skin cancer and cervical cancer in situ disease-free status ≥ 3 years
- Lactating women
- Unlikely to comply with study procedures, restrictions, and requirements
- Judgment by the investigator that the patient should not participate into the study
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05337657
Start Date
June 2 2021
End Date
February 1 2024
Last Update
April 20 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032