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

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

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).

Inclusion Criteria:

• 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

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

• Phase II

  1. 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:
  2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;
  3. 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.

Exclusion Criteria:

• 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.