KCT0008350招募中Unknown
An open label, single arm, multicenter phase II study of zanidatamab in patients with HER2 positive salivary gland carcinoma
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Subjects with histologically confirmed salivary gland cancer aged 19 years or older
- •2)Locally progressive or metastatic disease that has been proven to show recurrence or progression when comparing imaging findings (CT, MRI, X-ray) taken within the last 9 months with imaging findings immediately before enrollment.
- •(** Disease progression must be documented according to the RECIST v1.1 criteria)
- •3)Subjects whose HER2-expression was confirmed as follows (one or more of the following)
- •?HER2 IHC 3+
- •?In case of HER2 IHC 2+, FISH or SISH was performed and the HER2/Chrome 17 ratio ≥ 2.0
- •?In case of HER2 IHC 0 or 1+, HER2 gene copy number was confirmed to be 7 copies or more by NGS
- •4)Subjects whose condition deteriorated after radical surgery or topical treatment and can no longer undergo surgery or topical treatment.
- •5)At least one measurable target lesion according to the RECIST version1.1 criteria must exist.
- •6)ECOG performance status 0 or 1.
- •7)Patients with confirmed adequate major organ function
- •-Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L
- •-Platelet count ≥ 75 x 109 /L
- •-Hemoglobin ≥ 9 g/dL
- •-If serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or calculated Ccr ? 50 mL/min
- •-AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (but ≤ 5 × ULN for subjects with liver metastases)
- •-Total bilirubin ≤ 1.5 x ULN
- •-Left ventricular ejection fraction (LVEF) ? 50%: adequate left ventricular function of the heart
- •8)Patients willing and able to comply with the trial protocol during the trial duration
- •9)Subjects who sign a written consent form prior to trial participation and understand that they have the right to withdraw consent from trial participation at any time without penalty.
排除标准
- •1)Toxicity associated with prior cancer treatment that has not resolved to Grade 1 or lower (≤ Grade 1), with the exception of the following: alopecia, neuropathy (which must be resolved to ≤ Grade 2); Congestive heart failure (CHF) must be ≤ Grade 1 in severity at onset and must have completely resolved
- •2)Subjects with a history of other cancers within the past 3 years, except for cured skin cancer (not malignant melanoma), cervical in situ carcinoma, and thyroid cancer without lymph node metastasis
- •3)Positive history of HIV (human immunodeficiency virus) test
- •4)Untreated chronic hepatitis B or chronic hepatitis B virus carrier with HBV DNA ≥ 20 IU/mL
- •Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 20 IU/mL) are not excluded. Patients taking antiviral drugs must have taken them for at least 2 weeks prior to treatment
- •5)Patients with active hepatitis C virus
- •Note: Negative hepatitis C antibody (anti-HCV) or negative hepatitis C antibody but HCV RNA <15 IU/mL are not excluded. Patients taking antiviral drugs must have taken them for at least 2 weeks prior to treatment
- •6)Subjects with uncontrolled central nervous system or brain metastases
- •7)Subjects who received chemotherapy, radiation therapy, or other clinical medications within 3 weeks prior to trial enrollment, except for palliative radiation therapy for non-target lesions (conducted within 2 weeks prior to trial enrollment) (other than Zanidatamab in relation to chemotherapy) It is possible for subjects to be enrolled even if subjects were treated with the other HER2 target agents and there is no line limit)
- •8)History of active primary immunodeficiency syndrome
- •9)Men or women of childbearing age who are unwilling to use contraceptive methods during the trial
- •10)If there is a plan for pregnancy or lactation during treatment or within 12 months from the last dose
- •11)Subjects of childbearing age who did not undergo a pregnancy test at baseline or obtained a positive result. (Postmenopausal women with amenorrhea for more than 12 months are considered to be of no fertility)
- •12)Subjects who have experienced clinically significant heart disease (e.g., congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia, etc.) or myocardial infarction within the past 6 months
- •13)Subjects with a history of uncontrolled seizures, central nervous system disorders, or psychiatric disorders judged to be clinically significant by the investigator, which may interfere with the understanding of written consent or affect compliance with investigation product administration
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