NCT05117931进行中（未招募）2 期
Phase II Study of Amivantamab in EGFR or MET- Amplified Esophagogastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 9
- 主要终点
- objective response rate
研究概览
简要总结
The purpose of this study is to see whether the study drug, amivantamab, is an effective treatment for people with EGFR- or MET-amplified esophagogastric cancer. The researchers will also look at whether amivantamab is a safe treatment that causes few or mild side effects in participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or legally authorized representative is willing and able to provide written informed consent.
- •Patients with previously treated metastatic or unresectable histologically-confirmed esophagogastric cancer who have received at least 1 line of therapy.
- •EGFR or MET amplification by tissue-NGS with copy number >8 and/or ctDNA amplification by any FDA and CLIA-approved assay
- •No prior receipt of an EGFR or MET inhibitor for esophagogastric cancer. (Note: if a patient previously received a EGFR inhibitor, but subsequently demonstrated a MET amplification, or previously received a MET inhibitor, but subsequently demonstrated an EGFR-amplification, inclusion is permitted).
- •Patients with HER2+ (IHC 3+ or IHC 2+/FISH+) tumors must have progressed on trastuzumab.
- •Measurable disease based on RECIST 1.
- •≥ 18 years of age on day of signing informed consent.
- •Have an ECOG performance status of 0, 1, or
- •Adequate organ function, defined as:
- •A. Hemoglobin ≥9 g/dL
- •B. ANC ≥1.0 x 10^9 /L
- •C. Platelets ≥75 x 10^9 /L
- •D. AST and ALT ≤3 x ULN (≤5 x ULN for subjects with liver metastases)
- •E. Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits
- •F. Serum creatinine <1.5 x ULN or if available, calculated or measured creatinine clearance >50 mL/min/1.73 m^2
- •Women of childbearing potential and male patients with women of childbearing potential partners must be willing to use an adequate method of contraception
排除标准
- •Prior chemotherapy, targeted small molecule therapy, or biological therapy, within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (excluding alopecia).
- •If subject received major surgery, they must have recovered adequately prior to starting therapy.
- •Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- •Known active hepatitis B (e.g., HBsAg reactive or polymerase chain reaction detectable).
- •Note: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.
- •Known active hepatitis C (e.g., HCV RNA [qualitative] is detected).
- •Note: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.
- •Other clinically active or chronic liver disease.
- •Subject has uncontrolled inter-current illness, including but not limited to poorly controlled diabetes, ongoing or active infection (i.e., has discontinued all antibiotics for at least one week prior to first dose of study drug), or psychiatric illness/social situation that would limit compliance with study requirements. Subjects with medical conditions requiring chronic continuous oxygen therapy are excluded.
- •Pulmonary embolism (PE) and deep vein thrombosis (DVT), within 1 month of start of study drug.
- •Myocardial infarction, unstable angina, stroke, transient ischemic attach (TIA), or coronary/peripheral artery bypass graft, or any acute coronary syndrome within 6 months of start of study drug.
- •Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of start of study drug.
- •Interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents that is unresolved or resolved within the last 3 months.
- •Immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment.
- •Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator.
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 6 months after the last dose of trial treatment.
- •Prisoners, or subjects who are compulsory detained.
研究组 & 干预措施
Amivantamab
Experimental
Patients will receive amivantamab intravenously weekly for the first cycle, and biweekly subsequently at a dose of 1050mg (patients <80kg) or 1400mg (patients ≥80kg). The initial dose will be administered over 2 days in split doses in order to mitigate the risk of infusion reactions. Therapy will continue for up to 2 years or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reason to discontinue treatment occurs-whichever comes first.
干预措施: Amivantamab (Drug)
结局指标
主要结局
objective response rate
时间窗: 1 year
ORR; defined as complete response (CR) or partial response (PR)) by RECIST 1.1 criteria
次要结局
未报告次要终点
研究者
研究点 (9)
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