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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.2 个研究点分布在 1 个国家目标入组 154 人开始时间: 2023年4月13日最近更新: 2024年3月12日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
入组人数: 154
试验地点: 2
主要终点: Phase II recommended dose (P2RD)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

研究设计

研究类型: Interventional
分配方式: Non 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

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

排除标准

•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.

研究组 & 干预措施

TQB2930 for injection

Experimental

TQB2930 for injection,10 mg/kg, quaque week (QW), 21 day as a treatment cycle; TQB2930 for injection, 20 mg/kg, quaque 2 weeks (Q2W), 28 day as a treatment cycle; TQB2930 for injection,30 mg/kg, quaque 3 weeks (Q3W), 21 day as a treatment cycle.

干预措施: TQB2930 for injection (Drug)

TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)

Experimental

TQB2930 for injection 30mg/kg combined with paclitaxel (albumin-bound) for injection, 21 days for one treatment cycle

干预措施: TQB2930 for injection (Drug)

TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)

Experimental

TQB2930 for injection 30mg/kg combined with paclitaxel (albumin-bound) for injection, 21 days for one treatment cycle

干预措施: Paclitaxel for injection (albumin-bound) (Drug)

TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection

Experimental

TQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle.

干预措施: TQB2930 for injection (Drug)

TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection

Experimental

TQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle.

干预措施: TQB3616 capsule (Drug)

TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection

Experimental

TQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle.

干预措施: Fulvestrant injection (Drug)