CHIMERIC MONOCLONAL ANTIBODY AGAINST CARCINOEMBRYONIC ANTIGEN CONJUGATED TO FLUOROCHROME BM-104 for Brain metastases|Colorectal cancer

Inclusion criteria

• {"criterion_text":"- Signed informed consent prior to any study-mandated procedure.\n- 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- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.\n- Diagnosed with brain metastasis of colorectal origin and scheduled for a resection."}

Exclusion criteria

• {"criterion_text":"- History of any anaphylactic reaction; 7. Previous use of SGM-101.\n- Previous use of SGM-101.\n- Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.\n- Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate).\n- Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance."}

Primary endpoints

• {"endpoint_text":"- Based upon the primary objective: “To assess the performance of SGM-101 in the intraoperative detection of brain metastases of colorectal origin” we propose the following primary endpoint: Concordance rate between the pathology results with respect to the presence of cancer and the imaging assessment. This endpoint is chosen as this study serves as a proof of principle.","definition_or_measurement_approach":"Concordance rate between pathology results (presence of cancer in resected tissue) and imaging assessment (fluorescence signal). Measurement by comparing histopathology of resected lesions to intraoperative fluorescence imaging assessment and calculating concordance rate."}

Secondary endpoints

• {"endpoint_text":"- Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology in terms of both CEA expression and tumor status.\n- Modification of operative plan due to imaging (e.g. extension, reduction of resection margins, or additional resection) and change in postoperative treatment will be recorded.\n- Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue.\n- - Treatment-emergent (serious) adverse events ((S)AEs). - Concomitant medication - Vital signs o Pulse Rate (bpm) o Systolic blood pressure (mmHg) o Diastolic blood pressure (mmHg) o Body temperature o Glasgow Coma Scale o Monitoring of unpredicted seizures o Monitoring of unpredicted focal deficits","definition_or_measurement_approach":"1) Compare intraoperative fluorescence assessment to histopathology including assessment of CEA expression and tumor status to determine concordance. 2) Record any intraoperative changes to surgical plan attributable to imaging and relate these changes to pathological status of resected tissue. 3) Calculate tumor-to-background ratio (TBR) for fluorescence in malignant and benign tissue. 4) Record treatment-emergent (S)AEs, concomitant medication, and monitor vital signs and neurological events as listed."}

Netherlands

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

16-10-2024

Processing Time Days

5

Number Of Sites

2

Number Of Participants

10

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 S.A.S.","duties_or_roles":"Manufacturer/supplier of the investigational product (SGM-101)","organisation_type":""}