NL-OMON54662招募中3 期
Multicenter, semi-blinded, randomized, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody, for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer. - SGM-CLIN03
SurgiMab0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
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
- 18 至 64（—）
入选标准
- •1. Patients aged over 18 years old;
- •2. Patients should be scheduled for curative colorectal cancer surgery of
- •primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal
- •cancer or peritoneal metastasized colorectal cancer;
- •3. Female patients should not be of child-bearing potential (i.e., women with
- •functioning ovaries who have a documented tubal ligation or hysterectomy,
- •ovariectomy or women who are post-menopausal) nor breastfeeding. Women of
- •child-bearing potential, including women with a documented tubal ligation, will
- •included provided that they have a negative highly sensitive urine pregnancy
- •test or a negative
- •serum pregnancy test at the day of the injection and agree to practice adequate
- •contraception
- •for 30 days prior to administration of investigational product, and 3090 days
- •after completion
- •of injection. A postmenauposal state is defined as no menses for 12 months
- •alternative medical cause. A high follicle stimulating hormone (FSH) level in
- •the postmenopausal
- •range may be used to confirm a post-menopausal state in women not using hormonal
- •contraception or hormonal replacement therapy. However, in the absence of 12
- •amenorrhea, a single FSH measurement is insufficient.
- •Acceptable forms of highly effective contraception methods are methods that can
- •achieve a failure
- •rate of less than 1% per year when used consistently and correctly are
- •considered as highly
- •effective birth control methods. Such methods include:
- •Combined (estrogen and progestogen containing) hormonal contraception
- •associated with
- •inhibition of ovulation:
- •o Intravaginal;
- •o Transdermal.
- •Progestogen-only hormonal contraception associated with inhibition of
- •o Injectable;
- •o Implantable.
- •Intrauterine device (IUD) 2;
- •Intrauterine hormone-releasing system (IUS) 2;
- •Bilateral tubal occlusion 2;
- •5. STUDY POPULATION
- •5.1. INCLUSION CRITERIA
- •SGM-CLIN03 Version <4.1> - The Netherlands
- •SurgiMab 08/02/2023
- •Male sterilization (with the appropriate post-vasectomy documentation of the
- •sperm in the ejaculate). For female subjects on the study, the vasectomized
- •male partner
- •should be the sole partner for that subject.
- •True abstinence: When this is in line with the preferred and usual lifestyle
- •of the subject and
- •only if defined as refraining from heterosexual intercourse during the entire
- •period of risk
- •associated with the study treatments. Periodic abstinence (e.g. calendar,
- •symptothermal, post-ovulation methods) and withdrawal are not acceptable
- 另有 3 项未显示
排除标准
- •1. Other malignancies, either currently active or diagnosed in the last 5 years,
- •except for adequately treated in situ carcinoma of the cervix and basal or
- •squamous cell skin carcinoma;
- •2. Primary appendiceal cancer;
- •3. Laboratory abnormalities defined as:
- •- Aspartate AminoTransferase, Alanine AminoTransferase, Gamma
- •Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the
- •- Total bilirubin above 2 times the ULN or;
- •- Serum creatinine above 1.5 times the ULN or;
- •- Platelet count below 100 x 109/L or;
- •- Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
- •4. Known positive test for human immunodeficiency virus (HIV), hepatitis B
- •surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with
- •untreated serious infections;
- •5. Use of another investigational drug during 4 weeks before the Injection Day.
- •6. Any condition that the investigator considers it would potentially
- •jeopardize the patient*s well-being or the study objectives, such as severe
- •anaphylactic reaction in medical history, previous allergic reaction to SGM-101
- •or to any excipient present in the product or known hypersensitivity to murine
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