NCT07047365招募中3 期
A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Evaluating TQB2930 Combined With Investigator's Choice of Chemotherapy Versus Trastuzumab Combined With Investigator's Choice of Chemotherapy in the Treatment of HER2-Positive Advanced Breast Cancer
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.75 个研究点 分布在 1 个国家目标入组 416 人开始时间: 2025年7月25日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 416
- 试验地点
- 75
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy in subjects with HER2-positive advanced breast cancer who have received at least two prior lines of anti-HER2 therapy in the advanced station.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in this study and sign the informed consent form;
- •Age: 18-75 years (at time of signing Informed Consent Form (ICF); Eastern Cooperative Oncology Group (ECOG) performance status ≤1; estimated life expectancy >3 months;
- •Cytologically or histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive recurrent or metastatic breast cancer;
- •Received ≥2 prior lines of anti-HER2 targeted therapy in the advanced setting;
- •At least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria (excluding brain lesions);
- •Willing to receive one of the investigator-selected chemotherapy regimens;
- •Adequate organ function;
- •Female subjects of childbearing potential must agree to use effective contraception (e.g., Intrauterine Device (IUD), oral contraceptives, or condoms) during the study and for 6 months after study completion.
排除标准
- •Concurrent Diseases and Medical History:
- •Other malignancies within 5 years before randomization or concurrent malignancies (except adequately treated non-melanoma skin cancer, in situ cervical cancer, or other cancers with curative treatment and no recurrence for ≥3 years);
- •Uncontrolled toxicities (>CTCAE Grade 1) from prior therapies (excluding alopecia);
- •Major surgery, open biopsy, or significant traumatic injury within 28 days before randomization;
- •Non-healing wounds or fractures;
- •Arterial/venous thromboembolic events within 6 months before randomization;
- •History of drug abuse or psychiatric disorders that may affect compliance;
- •Poorly controlled hypertension (e.g., Systolic Blood Pressure (SBP) >160 mmHg despite treatment);
- •≥Grade 2 myocardial ischemia/infarction, arrhythmias, or congestive heart failure (New York Heart Association （NYHA）Class ≥II);
- •Active or uncontrolled severe infections (≥CTCAE Grade 2);
- •Known chronic hepatitis B;
- •Active syphilis infection;
- •Renal failure requiring hemodialysis/peritoneal dialysis;
- •Immunodeficiency disorders (e.g., Human Immunodeficiency Virus (HIV) ;
- •Poorly controlled diabetes;
- •Urine protein ≥++ on dipstick with 24-hour urine protein >1.0 g;
- •Epilepsy requiring medication.
- •Tumor-Related Conditions and Treatments:
- •Chemotherapy, radiotherapy, or immunotherapy within 4 weeks before randomization (or within 5 half-lives of prior drugs, whichever is shorter);
- •Chinese herbal medicines with approved antitumor indications (per National Medical Products Administration (NMPA) labeling) within 2 weeks;
- •Severe Bone Lesions from bone metastases;
- •Untreated brain metastases, Leptomeningeal metastases, or carcinomatous meningitis;
- •Prior HER2-targeted therapy-induced Left Ventricular Ejection Fraction (LVEF) decline to <50% or absolute reduction >15%;
- •Uncontrolled or symptomatic Hypertension requiring ongoing bisphosphonates;
- •Uncontrolled cancer-related pain;
- •Existed Lymphangitis Carcinomatosa or uncontrolled effusions;
- •Use of Immunosuppressant or systemic corticosteroids (≥10 mg/day prednisone equivalent) within 2 weeks.
- •Severe hypersensitivity to monoclonal antibodies;
- •Participation in other antitumor clinical trials with investigational drugs within 4 weeks before randomization;
- •Any condition deemed by the investigator to jeopardize subject safety or study completion.
研究组 & 干预措施
TQB2930+ chemotherapy
Experimental
Subjects will receive TQB2930 injection in combination with chemotherapy agents on Day 1 (D1) of each cycle. TQB2930 will be administered at a dose of 30 mg/kg every 3 weeks (Q3W), Each treatment cycle lasts 21 days.
干预措施: TQB2930+ chemotherapy (Drug)
Trastuzumab+ chemotherapy
Active Comparator
Subjects will receive trastuzumab in combination with chemotherapy agents on Day 1 (D1) of each cycle. The initial dose of trastuzumab is 8 mg/kg, followed by a maintenance dose of 6 mg/kg administered every 3 weeks (Q3W), Each treatment cycle lasts 21 days.
干预措施: Trastuzumab+ chemotherapy (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years
Independent Imaging Review Committee (IRC)-assessed PFS
Progression-free survival (PFS)
时间窗: Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years
Independent Imaging Review Committee (IRC)-assessed PFS
次要结局
- Duration of Response (DOR)(From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 2 years)
- PFS assessed by Investigator(Baseline up to Investigator-Assessed investigator, approximately 1 years)
- Proportion of subjects achieving partial response (PR)(From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years)
- Adverse event rate(From baseline until 90 days after the last dose or initiation of new antitumor therapy, whichever occurs first)
- Plasma concentration of TQB2930(Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 30 minutes after dosing on Cycle 4 Day 1 and Cycle 7 Day 1, each cycle is 21 days)
- Overall survival (OS)(From date of the first dose until the date of death from any cause, up to approximately 2 years)
- Anti-Drug Antibody (ADA) Positivity Rate(Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 , and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days)
- Clinical Benefit Rate (CBR)(From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first) , up to approximately 1 years)
- Objective Response Rate (ORR)(From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years)
- PFS assessed by Investigator(Baseline up to Investigator-Assessed investigator, approximately 1 years)
- Overall survival (OS)(From date of the first dose until the date of death from any cause, up to approximately 2 years)
- Duration of Response (DOR)(From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 2 years)
- Proportion of subjects achieving partial response (PR)(From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years)
- Objective Response Rate (ORR)(From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years)
- Clinical Benefit Rate (CBR)(From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first) , up to approximately 1 years)
- Adverse event rate(From baseline until 90 days after the last dose or initiation of new antitumor therapy, whichever occurs first)
- Plasma concentration of TQB2930(Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 30 minutes after dosing on Cycle 4 Day 1 and Cycle 7 Day 1, each cycle is 21 days)
- Anti-Drug Antibody (ADA) Positivity Rate(Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 , and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days)
- Anti-Drug Antibody (ADA) Positivity Rate(Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days)
研究者
研究点 (75)
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