TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Препарат TQB2930+ chemotherapy
  TQB2930 injection is a HER2 bispecific antibody drug； Chemotherapy: Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.
• Препарат Trastuzumab+ chemotherapy
  Trastuzumab is a HER2-specific targeted drug； Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years]

Вторичные конечные точки (10)

• PFS assessed by Investigator [Срок оценки: Baseline up to Investigator-Assessed investigator, approximately 1 years]
• Overall survival (OS) [Срок оценки: From date of the first dose until the date of death from any cause, up to approximately 2 years]
• Duration of Response (DOR) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From baseline until 90 days after the last dose or initiation of new antitumor therapy, whichever occurs first]
• Plasma concentration of TQB2930 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 75 центров

• The First Affiliated Hospital of Bengbu Medical College — Bengbu
• Anhui Provincial Hospital( The First Affiliated Hospital of USTC) — Хэфэй
• The Second Affiliated Hospital of Anhui Medical University — Хэфэй
• The Fifth Medical Center of Chinese People's Liberation Army General Hospital — Пекин
• Chong Qing University Cancer Hospital — Чунцин
• Fuzhou First Generel Hospital Affiliated with Fujian Medical University — Фучжоу
• The First Hospital of Lanzhou University — Lanzhou
• Gansu Cancer Hospital — Lanzhou
• … и ещё 67 центров

Идентификаторы

NCT: NCT07047365 · TQB2930-III-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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