A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors
关于
这个临床试验研究的是实体肿瘤. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. 这被称为晚期或转移性癌症.
Participants in this study must have breast cancer or gastric cancer. 参与者必须患有携带HER2的肿瘤. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2.
This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. adc被设计成附着在癌细胞上并杀死它们.
这个临床试验使用了一种叫做图卡替尼的药物, which has been approved to treat cancer in the United States and some other countries. 该药物以品牌名称TUKYSA®销售.
这项研究将测试DV的安全性和效果, 有或没有图卡替尼, 对于患有实体瘤的参与者. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.
资格
入选标准:
一般纳入标准
- 根据RECIST v1可测量的疾病.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
剂量递增阶段纳入标准
- Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast carcinoma
- 局部进展，不可切除或转移期
- HER2 status IHC 1+ or higher by most recent local assessment.
- Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies.
队列A (her2 -低乳腺癌)纳入标准
- Histologically or cytologically confirmed diagnosis of breast carcinoma
- 局部进展，不可切除或转移期
- HER2-low status determined by most recent local assessment (IHC 1+ or IHC 2+/ISH-negative)
- 既往治疗要求
- No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC.
- Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated
- 有进展吗, 或者不耐受, T-DXd, sacituzumab 政府itecan, 或其他拓扑异构酶I抑制剂治疗, 如果可作为当地标准护理治疗
- Participants with HR+ tumors must have endocrine therapy refractory disease:
- Progressed on ≥2 lines of endocrine therapy for LA/mBC AND had received a CDK4/6 inhibitor in the adjuvant or metastatic setting OR
- Progressed on 1 line of endocrine therapy for LA/mBC AND had a relapse while on adjuvant endocrine therapy after definitive surgery for primary tumor AND had received a CDK4/6 inhibitor in the adjuvant or advanced setting
- HR阴性的参与者, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab with chemotherapy 如果可作为当地标准护理治疗.
队列B (HER2+乳腺癌)纳入标准
- Histologically or cytologically confirmed diagnosis breast carcinoma
- 局部进展，不可切除或转移期
- HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
- 参加者必须具备:
- Received prior trastuzumab, pertuzumab and a taxane 如果可作为当地标准护理治疗.
- 有进展吗, 或者不耐受, T-DXd 或其他拓扑异构酶I抑制剂治疗
- No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC
Cohort C (HER2-Low Gastric or Gastroesophageal Junction Adenocarcinoma) Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
- 局部进展，不可切除或转移期
- HER2-low expression defined as IHC 1+ or IHC 2+/ISH-negative determined by most recent local assessment
- Willing and able to provide archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks
- 参加者必须已收到:
- 既往全身治疗铂, 氟尿嘧啶, or taxane for locally advanced unresectable or metastatic disease
- Progression within 6 months of last dose of (neo)adjuvant cytotoxic chemotherapy is considered as 1 line of systemic therapy for LA/mGC/GEJC
- 允许既往抗pd -(L)1治疗
- No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADC) for LA/mGC/GEJC
- Must not have received prior treatment with HER2 directed therapy
排除标准:
- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin or tucatinib
- 既往使用adc治疗MMAE有效载荷
- 既往使用图卡替尼治疗
- 中枢神经系统活动性和/或轻脑膜转移.
- Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment
- History of other invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
- Unable to swallow oral tablets or capsules or any significant GI disease which would preclude the adequate oral absorption of medications
加入这个试验
- 皇冠hga025大学洛杉矶分校韦斯特伍德