A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer

NCT05775575 | Unknown Phase 1

• 1 other identifier: TQB3909-Ib/II-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicity (DLT)

  DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle.

  At the end of Cycle 1 (Cycle 1, Day 28)

• Maximum tolerated dose (MTD)

  MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

  At the end of Cycle 1 (Cycle 1, Day 28)

• Recommended Phase II Dose (RP2D)

  DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3909 tablets in adult patients with Breast cancers

  Baseline up to 24 months

Secondary Outcomes (8)

• Time to reach maximum (peak)plasma concentration (Tmax)

  before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

• Peak concentration (Cmax)

  before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

• Terminal half-life (T1/2)

  before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

• Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

  before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

• Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)

  before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

Study Arms (1)

TQB3909 tablets

EXPERIMENTAL

200-1000mg of TQB3909 tablets once a day; Oral administration under fast condition, 28 days as a cycle.

Drug: TQB3909 tablets

Interventions

TQB3909 tablets DRUG

TQB3909 is an inhibitor targeting BCL-2 protein

TQB3909 tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: female patient aged from 18 to 75 years old, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Concomitant disease and medical history:
• There were other malignant tumors in 3 years before the first medication.
• Has multiple factors affecting oral medication;
• Unalleviated toxicity ≥ grade 1 due to any previous therapy;
• 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:
• Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
• have received radiotherapy, other antineoplastic therapy within 2 weeks prior to the first dose;
• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

Study Design

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

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: March 20, 2023
• Study Start: March 2, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 20, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)