A Phase I Study Assessing the Safety and Performance of SGM-101, a Fluorochrome-Labeled Anti-Carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Neoplastic Lesions in Patients with Cancer of the Colorectum or Pancreas - Phase I of SGM-101 in patients with cancer of the colorectum or pancreas

Surgimab0 sites85 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Observational invasive

Sponsor

Surgimab

•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.

•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:

Not specified