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.
- Conditions
- colorectal cancer10017943
- Registration Number
- NL-OMON54662
- Lead Sponsor
- SurgiMab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
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
be
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
without an
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
months of
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 Oral;
o Intravaginal;
o Transdermal.
• Progestogen-only hormonal contraception associated with inhibition of
ovulation:
o Oral;
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
40
• Male sterilization (with the appropriate post-vasectomy documentation of the
absence of
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,
ovulation,
symptothermal, post-ovulation methods) and withdrawal are not acceptable
methods of
contraception
4. Patients should be capable and willing to give informed consent before study
specific procedures.
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
ULN or;
- 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
proteins.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy endpoint P1 (detection rate):<br /><br>The detection rate is agregated at the patient level and corresponds to the<br /><br>rate of patients who have<br /><br>at least one zone of interest identified under NIR only (not detectable under<br /><br>WL) and pathologically<br /><br>confirmed as cancer [WL negative, NIR positive, pathology positive].<br /><br>Key secondary efficacy endpoint P2 (conservative surgery benefit):<br /><br>The key secondary efficacy endpoint is agregated at the patient level and<br /><br>corresponds to the rate of<br /><br>patients who have more [WL positive, NIR negative, pathology negative lesions]<br /><br>(NIR true negatives)<br /><br>than [WL negative, NIR positive, pathology negative] (NIR false positive)<br /><br>lesions, i.e. a net benefit in<br /><br>numbers of negative lesions wrongly resected.</p><br>
- Secondary Outcome Measures
Name Time Method