CHIMERIC MONOCLONAL ANTIBODY AGAINST CARCINOEMBRYONIC ANTIGEN CONJUGATED TO FLUOROCHROME BM-104 for Rectal cancer

Inclusion criteria

• {"criterion_text":"- Patients aged over 18 years old\n- 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.\n- 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)\n- Patients should be capable and willing to give signed informed consent before study specific procedures."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery).\n- Patient with a history of a clinically significant allergy.\n- Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential.\n- 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.\n- Any condition that the investigator considers to be potentially jeopardizing the patients’ well-being or the study objectives.\n- Previous administration of SGM-101."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the rate of patients with R0 resections. This endpoint is based on the primary objective of clinical benefit of FGOS combined with SGM-101 as the intraoperative imaging agent.","definition_or_measurement_approach":"Rate of patients with R0 resections; based on the clinical benefit of FGOS combined with SGM-101 as the intraoperative imaging agent."}

Secondary endpoints

• {"endpoint_text":"- Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology.\n- For every removed specimen: rate of false negatives, false positives, true negatives and true positives concerning fluorescence, with histopathology as the gold standard.\n- Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue.\n- Modification of operative plan due to imaging (e.g. more/less extensive resection or adjustment of IORT) and change in postoperative treatment will be recorded.\n- 30-day mortality and 30-day complication rates.\n- 2-year overall survival, 2-year disease free survival and 2-year local recurrence free survival.","definition_or_measurement_approach":"Concordance: comparison of intraoperative fluorescence assessment with histopathology results. False/true positive/negative rates: calculated per removed specimen using histopathology as gold standard. TBR: tumor-to-background fluorescence ratio (fluorescent signal of tumor tissue compared to fluorescence of surrounding normal tissue). Modification of operative plan: recorded changes in surgical plan attributable to imaging (e.g. extent of resection, application of IORT) and postoperative treatment changes. 30-day outcomes: recorded 30-day mortality and complication rates. 2-year outcomes: overall survival, disease-free survival and local recurrence-free survival assessed at 2 years."}

Netherlands

Earliest CTIS Part Ii Submission Date

27-09-2024

Latest Decision Or Authorization Date

01-10-2024

Processing Time Days

4

Number Of Sites

7

Number Of Participants

203

Primary sponsor

Full Name

Academisch Ziekenhuis Leiden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"SurgiMab","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"KWF","duties_or_roles":"Source of monetary support","organisation_type":""}