Multicenter, open-label, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for locally advanced or recurrent rectal cancer patients undergoing curative surgery.

Multicenter, open-label, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for locally advanced or recurrent rectal cancer patients undergoing curative surgery. - SGM-101 in Locally Advanced and Recurrent Rectal Cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56317

Enrollment

203

Registered

2019-07-18

Start date

2019-11-04

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

The proposed dose is 10 mg to be administered intravenously over 30 minutes 4 (+/-1) days prior to surgery. During surgery a fluorescence imaging device will be used to intraoperatively visualize tu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged over 18 years old; 2. All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment. 3. Patients should be scheduled and eligible for surgery because of a clinical diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or recurrent rectal cancer. (UICC. TNM classification of diseases for oncology. 3rd ed. Geneva: World Health Organization; 2000) 4. Patients should be capable and willing to give signed informed consent before study specific procedures.

Exclusion criteria

Exclusion criteria: 1. Other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma. 2. Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery) 3. Patient with a history of a clinically significant allergy. 4. Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential; 5. Laboratory abnormalities defined as: a. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or; b. Total bilirubin above 2 times the ULN or; c. Serum creatinine above 1.5 times the ULN or; d. Platelet count below 100 x 109/L or; e. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males); f. 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; 6. Any condition that the investigator considers to be potentially jeopardizing the patients* well-being or the study objectives. 7. Previous administration of SGM-101

Design outcomes

Primary

Measure	Time frame
The primary objective is based on the clinical benefit of FGOS combined with SGM-101 as the intraoperative imaging agent. The corresponding endpoint is the rate of patients with R0 resections.	—

Secondary

Measure	Time frame
- To determine the effect of fluorescence guided surgery combined with SGM-101 on intra-operative decision making. The corresponding endpoint is the clinical benefit at the patient level; a positive change in surgical plan or post-surgical management. Moreover, standard of care surgery will be compared to fluorescence guided surgery and assessing if the latter allowed to remove any additional histopathologically confirmed malignant lesions and/or to resect less non-malignant tissue. - To determine the performance of SGM-101 in the intra-operative detection of rectal cancer. The corresponding endpoint will be the tumor-to-background ratio. In addition, the concordance between fluorescent signal and histopathologic results will be defined. - To compare intra-operative fluorescence imaging with SGM-101 and histopathology. The corresponding endpoints will be the rate of false negatives, false positives, true negatives and true positives. - To determine the changes in surgical planning due to FGOS combined with SGM-101 on mortality and postoperative complications caused by the surgical procedure. The corresponding endpoints are 30-day mortality and 30-day complication rates in order to substantiate the benefit/risk assessment of the use of SGM-101. - To determine the effect of fluorescence guided surgery combined with SGM-101 on overall and disease-free survival, and to determine the effect on local recurrence rates. The corresponding endpoints will be the 2-year overall survival, 2-year disease-free survival and 2-year local recurrence free survival. Tolerability / safety endpoints - Treatment-emergent (serious) adverse events ((S)AEs). - Concomitant medication - Vital signs (pulse rate, systolic blood pressure, diastolic blood pressure and body temperature)	—

Measure

Time frame

- To determine the effect of fluorescence guided surgery combined with SGM-101 on intra-operative decision making. The corresponding endpoint is the clinical benefit at the patient level; a *positive* change in surgical plan or post-surgical management. Moreover, standard of care surgery will be compared to fluorescence guided surgery and assessing if the latter allowed to remove any additional histopathologically confirmed malignant lesions and/or to resect less non-malignant tissue. - To determine the performance of SGM-101 in the intra-operative detection of rectal cancer. The corresponding endpoint will be the tumor-to-background ratio. In addition, the concordance between fluorescent signal and histopathologic results will be defined. - To compare intra-operative fluorescence imaging with SGM-101 and histopathology. The corresponding endpoints will be the rate of false negatives, false positives, true negatives and true positives. - To determine the changes in surgical planning due to FGOS combined with SGM-101 on mortality and postoperative complications caused by the surgical procedure. The corresponding endpoints are 30-day mortality and 30-day complication rates in order to substantiate the benefit/risk assessment of the use of SGM-101. - To determine the effect of fluorescence guided surgery combined with SGM-101 on overall and disease-free survival, and to determine the effect on local recurrence rates. The corresponding endpoints will be the 2-year overall survival, 2-year disease-free survival and 2-year local recurrence free survival. Tolerability / safety endpoints - Treatment-emergent (serious) adverse events ((S)AEs). - Concomitant medication - Vital signs (pulse rate, systolic blood pressure, diastolic blood pressure and body temperature)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)