Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas
Sponsored by Surgimab
About this trial
Last updated 7 years ago
Study ID
SGM-CLIN02
Status
Completed
Type
Interventional
Phase
Phase 1
Placebo
No
Accepting
18+ Years
All Sexes
Trial Timing
Ended 7 years ago
What is this trial about?
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.
What are the participation requirements?
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.