a study of tqb2930 for injection monotherapy or combination therapy in patients with recurrent/metastatic breast cancer

Conditions: Metastatic Breast Cancer; Recurrent Breast Cancer; Advanced Malignancies

Summary: 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).


Eligibility criteria:
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 \ 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.