cancer of colon colorectal and pancreatic carcinoma rectum and pancreas
Conditions
Interventions
None listed
Sponsors
Surgimab
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged over 18 years old; 2. Patient should be scheduled and eligible for surgery because of a clinical diagnosis of cancer of the colon rectum or cancer of the pancreas; 3. Both pancreatic and colorectal cancer patients: Circulating plasma CEA * the upper limit of normal range (eg * 3.0 ng / ml); Patient suffering from recurrences and metastasis of colorectal cancer: Rising circulating plasma CEA); 4. Patients should be capable and willing to give informed consent before study specific procedures.
Exclusion criteria
Exclusion criteria: 1. Anticancer therapy (e.g. chemotherapy, radiotherapy (except for routine pre-operative radiotherapy in rectal cancer), targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion; 2. History of a clinically significant allergy; 3. Circulating plasma concentration CEA * 300 ng / ml; 4. 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; 5. Patients pregnant or breastfeeding (pregnancy should be ruled out by an assay of *hCG plasma within two weeks prior to administration of the conjugate), lack of effective contraception in male or female patients with reproductive potential; 6. Laboratory abnormalities defined as: Rectal cancer patients only: * Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or; * Total bilirubin above 2 times the ULN or; Both pancreatic and colorectal cancer patients: * Serum creatinine above 1.5 times the ULN or; * Absolute neutrophils counts below 1.5 x 109/L or; * Platelet count below 100 x 109/L or; * Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males). 7. 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; 8. Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability (primary endpoint) Tolerability/safety will be assessed using routine clinical measures such treatment-emergent adverse events, blood pressure, heart rate, temperature, peripheral oxygen saturation, respiratory rate, skin examination, and routine laboratory assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance (secondary endpoint) Performance of SGM-101 will be defined by tumor to background ratio (TBR) for fluorescence, and the concordance between the intraoperative fluorescence assessment of suspected lesions and their histopathology. In addition after resection, margins will be assessed using fluorescence imaging to detect potential irradical resection. Pharmacokinetics (secondary endpoint) Cmax, T*, AUC, Tmax, Clearance. In addition, the relationship between pharmacokinetics and performance will be assessed. | — |
Countries
Netherlands
Outcome results
None listed