A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer

Официальное название

A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent / Metastatic Breast Cancer

Обзор

This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).

Вмешательства

• Препарат TQB2930 for injection
  TQB2930 for injection is a HER2 bispecific antibody.
• Препарат Paclitaxel for injection (albumin-bound)
  It is an anti-microtubule chemotherapy drug
• Препарат TQB3616 capsule
  TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
• Препарат Fulvestrant injection
  Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol
• Препарат Capecitabine tablets
  Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.
• Препарат Vinorelbine tartrate injection
  Vinorelbine is an anti-tumor drug of vinca alkaloids.
• Препарат Eribulin mesylate injection
  Eribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic mechanism.
• Препарат gemcitabine hydrochloride for injection
  Gemcitabine is a cell cycle specific anti-metabolic anticancer agent

Первичные конечные точки

• Maximum tolerated dose (MTD) [Срок оценки: Baseline up to 4 months]
• Phase II recommended dose (P2RD) [Срок оценки: Baseline up to 1 year]
• Investigators assessed Objective remission rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Срок оценки: Baseline up to 2 year]

Вторичные конечные точки (12)

• Immunogenicity [Срок оценки: Pre-dose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, each cycle is 21 or 28 days.]
• Peak concentration (Cmax), QW [Срок оценки: Pre-dose, 30 minuets, 4, 8, 24, 48, 72 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 8, each cycle is 21 days.]
• Peak concentration (Cmax), Q2W [Срок оценки: Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 15, Cycle 2 Day 15, each cycle is 28 days.]
• Peak concentration (Cmax), Q3W [Срок оценки: Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240, 336 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 3 Day 1, each cycle is 21 days.]
• Overall survival (OS) [Срок оценки: Baseline up to 4 years]
• Adverse event rate [Срок оценки: Baseline up to 2 years]
• Progression-free survival (PFS) [Срок оценки: Baseline up to 1 year]
• Disease control rate (DCR) [Срок оценки: Baseline up to 2 years]
• Duration of remission (DOR) [Срок оценки: Baseline up to 2 years]
• Clinical benefit rate (CBR) [Срок оценки: Baseline up to 2 years]
• Peak concentration (Cmax), arm 2 [Срок оценки: Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 28 days.]
• Peak concentration (Cmax), arm 3 and 4 [Срок оценки: Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 21 days.]

Критерии участия

Критерии включения

• Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\~1; The expected survival is over 3 months.
• Phase Ib

• Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification;
• Subjects with malignant tumors who have failed standard treatment or lack effective treatment;
• Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria
• Phase II

• Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology / histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes:
• Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;
• at least one measurable lesion that meets the RECIST 1.1 criteria.
• Major organs are functioning normally.
• Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy / urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study.

Критерии исключения

• Have occured other malignant tumors within 3 years prior to first dose.
• Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;
• Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;
• Long-term unhealed wounds or fractures;
• Arterial/venous thrombosis events occurred within 6 months before the first dose;
• Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders;
• Subject with any severe and/or uncontrolled disease;
• Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug;
• Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose;
• Severe bone injury due to bone metastasis;
• Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis;
• In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to <50% or absolute LVEF decreased >15%;
• Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes >360 mg/m2;
• Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy
• Patients with severe hypersensitivity after the use of monoclonal antibodies;
• Has participated in other antitumor clinical trials within 4 weeks prior to the first dose.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Affiliated Cancer Hospital of Chongqing University — Чунцин
• Affiliated cancer hospital of harbin medical university — Харбин

Идентификаторы

NCT: NCT06202261 · TQB2930-Ib/II-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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