KCT0009134尚未招募未知
Ph 1/2 study of Trastuzumab deruxtecan(T-DXd and Afatinib combination in HER2-low advanced gastric cancer (VIKTORY-2)
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 61
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Provision of fully informed consent prior to any study specific procedures.
- •2.Patients must be = 19 years of age
- •3.Has a pathologically documented advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction with at least one measurable lesion according to the modified RECIST 1.1 are eligible
- •4.HER2-low (HER2 1+, HER2 2+ (SISH negative))
- •5.Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- •6.ECOG performance status 0-1 with no deterioration between screening and the first dose of study treatment.
- •7.Patients must have a life expectancy = 3 months from proposed first dose date.
- •8.Patients must have had a washout period of 2 weeks for any prior therapy prior to the start of study drug. The following intervals between the end of the prior treatment and first dose of study drug must be observed:
- •-Major surgery = 4 weeks
- •-Radiation Therapy including palliative stereotactic radiation therapy to chest = 4 weeks
- •-Palliative stereotactic radiation therapy to other anatomic areas including whole brain radiation = 2 weeks
- •-Anti-Cancer chemotherapy [Immunotherapy (non-antibody based therapy)], retinoid therapy, hormonal therapy = 3 weeks
- •-Antibody based anti-cancer therapy = 4 weeks
- •-Targeted agents and small molecules = 2 weeks or 5 half-lives, whichever is longer
- •-Nitrosoureas or mitomycin C = 6 weeks
- •-TKIs approved for treatment of NSCLC =1 week (baseline CT scan must be completed after discontinuation of TKI
- •-Chloroquine/Hydroxychloroquine = 14 days
- •-Cell-free and CART, peritoneal shunt or drainage of pleural effusion, ascites or pericardial effusion = 2 weeks prior to screening assessment
- •9.Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
- •-Hemoglobin =8.0 g/dL (Red blood cell transfusion is not allowed within 1 week prior to the day)
- •-Absolute neutrophil count (ANC) = 1.5 x 109/L (G-CSF administration is not allowed within 2 weeks prior to the day)
- •-Platelet count =100 x 109/L (Platelet transfusion is not allowed within 1 week prior to the day)
- •-Total bilirubin = 1.5 x institutional upper limit of normal (ULN) or < 3×ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline
- •-AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be = 5x ULN
- •-Serum creatinine =1.5 x institutional ULN
- •-CrCl 30=mL/min as determined by Cockcroft Gault (using actual body weight)
- •-Serum albumin = 2.5 g/dL
- •-International normalised ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time = 1.5 × ULN
- •10.Female patients must be using a highly effective method of contraception (refer to the restrictions on P37) during the clinical trial and for 7 months after permanent discontinuation of the study drug. There must be evidence that patients are not breastfeeding, have a negative pregnancy test, or not of childbearing potential by meeting one of the following criteria at screening:
- •a.Post-menopausal women defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatment.
- •b.Documentation of irreversible surgical sterilisation by hysterectomy, bilatera
排除标准
- •1.Medical history of myocardial infarction within 6 months before registration, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV, Section 17.4), troponin levels consistent with myocardial infarction as defined according to American College of Cardiology (ACC) guidelines, unstable angina, or serious cardiac arrhythmia requiring treatment.
- •2.History of (non-infectious) ILD / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- •3.Has a pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART). (Drainage and CART are not allowed within 2 weeks prior to screening assessment)
- •4.Has uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
- •5.Active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1. Subjects with past or resolved hepatitis B virus (HBV) infection who are anti-HBc positive (+) are eligible only if they are HBsAg negative (-). Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- •6.Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who do not require treatment with steroids for at least three weeks may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment/randomization.
- •7.Has clinically significant corneal disease in the opinion of the investigator.
- •8.Prior treatment with an ADC which consists of an exatecan derivative that is a topoisomerase I inhibitor.
- •Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than chronic toxicities per the discretion of the investigator, eg, alopecia, peripheral neuropathy, proteinuria, controllable hypertension, and controllable diabetes) not yet resolved to National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, Grade =1 or baseline. Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to >Grade 2 for at least 3 months prior to [randomization/enrollment/Cycle 1 Day 1] and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, such as:
- •?Chemotherapy-induced neuropathy
- •?Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include:
- •a) Hypothyroidism/hyperthyroidism
- •b) Type 1 diabetes
- •c) Hyperglycaemia
- •d) Adrenal insufficiency
- •e) Adrenalitis
- •f) Skin hypopigmentation (vitiligo)
- •9.Any gastrointestinal condition that would preclude adequate absorption of afatinib including but not limited to inability to swallow oral medication, refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection, intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
- •10.Active or prior documented autoimmune or inflammatory disorders (including IBD [e.g. Ch
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