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Trial Title:
A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer
NCT ID:
NCT05775575
Condition:
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3909 tablets
Description:
TQB3909 is an inhibitor targeting BCL-2 protein
Arm group label:
TQB3909 tablets
Summary:
TQB3909 is an inhibitor targeting B-cell lymphoma (BCL)-2 protein. By binding to BCL-2
protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK),
BCL-2 associated X (BAX) protein and BCL-2 associated death (BAD) protein, promotes the
release of cytochrome c from mitochondria, phosphatidylserine eversion, stimulates
caspase 3/7 activity and caspase 3/9 cleavage, and induces apoptosis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Evidence of a personally signed and dated informed consent document indicating that
the patient has been informed of all pertinent aspects of the study.
- Age: 18 to 75 years old; female patient, an Eastern Cooperative Oncology Group
(ECOG) performance status of 0 to 1.
- Histopathologically confirmed HR positive and HER2 negative advanced or metastatic
breast cancer.
- Patients who have been treated with endocrine therapy and have experienced disease
progression.
- Patients previously treated with any CDK4/6 inhibitor and not treated with BCL-2
inhibitor.
- Has at least one measurable lesion according to Response Evaluation Criteria In
Solid Tumors (RECIST) v1.1 criteria
- The main organs function well;
- Female patient had no plans to become pregnant and voluntarily took effective
contraceptive measures from agree with the study to at least 6 months after the last
dose of study drug.
Exclusion Criteria:
-
1. Concomitant disease and medical history:
1. There were other malignant tumors in 3 years before the first medication.
2. Has multiple factors affecting oral medication;
3. Unalleviated toxicity ≥ grade 1 due to any previous therapy;
4. Major surgical treatment, open biopsy and obvious traumatic injury were
performed within 28 days before the study; e．Arteriovenous thrombotic events
occurred within 6 months before the first medication, such as cerebrovascular
accident (including transient ischemic attack, cerebral hemorrhage, cerebral
infarction), deep venous thrombosis and pulmonary embolism; f．Have a history of
psychotropic drug abuse and can not quit or have mental disorders; g．Subjects
with any severe and / or uncontrolled disease included: Cirrhosis, active
hepatitis, history of immunodeficiency;
- Tumor-related symptoms and treatment:
1. Has central nervous system metastases (CNS) and/or cancerous meningitis or
leptomeningeal carcinomatosis;
2. have received radiotherapy, other antineoplastic therapy within 2 weeks prior
to the first dose;
3. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring
recurrent drainage procedures.
- Known hypersensitivity to TQB3909, LHRH agonists (e.g., goserelin), or any
excipients.
- Subjects who have received the vaccine within 28 days prior to the first dose, or
are planning to receive the vaccine during the study period.
- Has Participated in other clinical trials within 4 weeks before first dose.
- According to the judgement of the investigators, there are other factors that may
lead to the termination of the study.
Gender:
Female
Gender based:
Yes
Gender description:
female patient aged from 18 to 75 years old, with an Eastern Cooperative Oncology Group
(ECOG) performance status of 0 to 1.
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Quchang Ouyang, Doctor
Phone:
+86 13973135318
Email:
oyqc1969@126.com
Start date:
March 2, 2023
Completion date:
December 2023
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05775575
