Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the visualization of CEA-expressing cancers during surgery. SGM-101 is injected 2 to 4 days before surgery and visualized using an optimized camera system.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Surgimab
• Collaborators: Catharina Ziekenhuis Eindhoven; Centre for Human Drug Research, Netherlands; Erasmus Medical Center; Leiden University Medical Center

Criteria

Inclusion Criteria:

• Patients aged over 18 years old;

• Patient should be scheduled and eligible for surgery because of a clinical diagnosis of cancer of the colon, rectum or cancer of the pancreas;

• 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

• Patients should be capable and willing to give informed consent before study specific procedures.

Exclusion Criteria:

• Anticancer therapy (e.g. chemotherapy, radiotherapy (except for routine pre-operative radiotherapy for colorectal cancer), targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion;

• History of a clinically significant allergy;

• Circulating plasma concentration CEA ≥ 300 ng / ml;

• 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;

• Patients pregnant or breastfeeding (pregnancy should be ruled out by an assay of βhCG plasma within 4±1 weeks prior to administration of the conjugate), lack of effective contraception in male or female patients with reproductive potential;

• Laboratory abnormalities defined as:

Colorectal 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 Upper Limit Normal (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);

• 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;

• Any condition that the investigator considers to be potentially jeopardizing the patients' wellbeing or the study objectives.