colorectal cancer
Conditions
Interventions
Eligible and consenting patients will be randomized 4:1 to one of two groups (A 
and B).
• Group A: SGM-101 injection followed by conventional then fluorescence tumor 
assessment.
• Group B: Saline injection followed by standard surgical treatment - 
conventional tumor
assessment
SGM-101 is a CEA-specific chimeric antibody conjugated with a NIR emitting 
fluorochrome,
developed as an intraoperative imaging agent for the delineation and/or 
detection of tumors.
The SGM-101 active ingredient is a covalent conjugate of the SGM-Ch511 anti-CEA 
chimeric
monoclonal antibody with the fluorochrome BM-104 (Figure 1). The BM-104 
fluorochrome is
conjugated to free amino groups of the antibody via a stable heterobifunctional 
linker and an amide
bond.
Sponsors
SurgiMab
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint P1 (detection rate): The detection rate is agregated at the patient level and corresponds to the rate of patients who have at least one zone of interest identified under NIR only (not detectable under WL) and pathologically confirmed as cancer [WL negative, NIR positive, pathology positive]. Key secondary efficacy endpoint P2 (conservative surgery benefit): The key secondary efficacy endpoint is agregated at the patient level and corresponds to the rate of patients who have more [WL positive, NIR negative, pathology negative lesions] (NIR true negatives) than [WL negative, NIR positive, pathology negative] (NIR false positive) lesions, i.e. a net benefit in numbers of negative lesions wrongly resected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment at the zone of interest level: For each zone of interest, a *fluorescence outcome* will be derived as either • positive (if the use of fluorescence led to a change in the surgical plan or post-surgery management of the patient that was beneficial, e.g. identification and resection of a metastatic lesion not visible with normal light, i.e. [WL negative, NIR positive, pathology positive], identification of R2 margins*) • negative (if the use of fluorescence led to a change in the surgical plan that was potentially deleterious, e.g. resection of some fluorescent tissue that was considered as normal with normal light and is confirmed as non-tumorous by pathology, i.e. [WL negative, NIR positive, pathology negative]) • neutral (if the use of fluorescence did not result in a change in the surgical plan, or if it induced a change in the plan that was neither beneficial nor detrimental). | — |
Countries
Netherlands
Outcome results
None listed