Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas
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|ClinicalTrials.gov Identifier: NCT02973672|
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : July 18, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Rectum Cancer Pancreas Cancer Metastatic Colorectal Cancer Recurrent Colorectal Carcinoma||Drug: SGM-101||Phase 1 Phase 2|
Surgery is the most important therapy for patients with cancer of the colon, rectum or pancreas. Complete resection, which is a crucial factor in the prognosis of a patient, is challenging as surgeons have to rely on visual appearance and palpation to discriminate between tumor and normal tissue.
Carcinoembryonic antigen (CEA) is a tumor-specific marker that is highly expressed in a number of tumors of epithelial origin (such as colorectal carcinoma and pancreas carcinoma) while it is minimally expressed in normal adult tissues. The compound that will be studied in this research project is SGM-101, a CEA-specific chimeric antibody conjugated with a near-infrared (NIR) emitting moiety. The hypothesis is that, following preoperative iv administration of SGM-101 in patients with carcinoma of the colon, rectum or pancreas, SGM-101 will bind to CEA expressing cancer cells and these cells can then be visualized with a NIR fluorescence imaging system, thereby increasing the chance of radical resection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Assessing the Safety and Performance of SGM-101, a Fluorochrome-labeled Anti-carcino-embryonic Antigen Monoclonal Antibody for the Detection of Neoplastic Lesions in Patients With Colorectal Cancer or Pancreatic Cancer|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||April 15, 2019|
|Actual Study Completion Date :||May 2019|
4 days before surgery, SGM-101 will be administered to the patient by intravenous injections.
- Number of patients with treatment-related adverse events [ Time Frame: up to 10 days after the surgery ]An Adverse Event (AE) is any untoward medical occurrence in a subject who is participating in a clinical study performed. The adverse event does not necessarily have to follow the administration of a study drug, or to have a causal relationship with the study drug. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory or vital sign finding), symptom, or disease temporally associated with the study participation, whether or not it is related to the study drug.
- Tumor-to-background ratio (TBR) for fluorescence [ Time Frame: day 4 ]
- Serum SGM-101 concentrations [ Time Frame: up to 1 month after surgery ]
Individual serum SGM-101 concentrations will be plotted versus time per individual using both a linear and log y-axis. Additionally, concentration versus time curves will be plotted per treatment group as a spaghetti plot.
Concentrations will be summarized by treatment group.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973672
|Catharina Ziekenhuis Eindhoven|
|Leiden University Medical Center|
|Leiden, Netherlands, 2333 CL|
|Erasmus Medical Center Cancer Institute|
|Principal Investigator:||Alexander L Vahrmeijer, MD, PhD||Leiden University Medical Center|
|Other Study ID Numbers:||
|First Posted:||November 25, 2016 Key Record Dates|
|Last Update Posted:||July 18, 2019|
|Last Verified:||July 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases