NCT02973672

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2016

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

3.3 years

First QC Date

November 16, 2016

Last Update Submit

July 16, 2019

Conditions

Colon CancerRectum CancerPancreas CancerMetastatic Colorectal CancerRecurrent Colorectal Carcinoma

Keywords

FluorescenceSurgeryCancerSGM-101Near InfraredImmunophotodetection

Outcome Measures

Primary Outcomes (1)

  • Number of patients with treatment-related adverse events

    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.

    up to 10 days after the surgery

Secondary Outcomes (2)

  • Tumor-to-background ratio (TBR) for fluorescence

    day 4

  • Serum SGM-101 concentrations

    up to 1 month after surgery

Study Arms (1)

SGM-101

EXPERIMENTAL
Drug: SGM-101

Interventions

SGM-101DRUG

4 days before surgery, SGM-101 will be administered to the patient by intravenous injections.

Also known as: SGM 101, SGM101
SGM-101

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

Location

Leiden University Medical Center

Leiden, 2333 CL, Netherlands

Location

Erasmus Medical Center Cancer Institute

Rotterdam, Netherlands

Location

Related Publications (3)

  • Lwin TM, Hoffman RM, Bouvet M. The future of tumour-specific fluorescence-guided surgery for pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):715-717. doi: 10.1016/S2468-1253(20)30123-0. Epub 2020 May 14. No abstract available.

    PMID: 32416765DERIVED

  • Schaap DP, de Valk KS, Deken MM, Meijer RPJ, Burggraaf J, Vahrmeijer AL, Kusters M; SGM-101 study group. Carcinoembryonic antigen-specific, fluorescent image-guided cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for metastatic colorectal cancer. Br J Surg. 2020 Mar;107(4):334-337. doi: 10.1002/bjs.11523. Epub 2020 Jan 21.

    PMID: 31960953DERIVED

  • Boogerd LSF, Hoogstins CES, Schaap DP, Kusters M, Handgraaf HJM, van der Valk MJM, Hilling DE, Holman FA, Peeters KCMJ, Mieog JSD, van de Velde CJH, Farina-Sarasqueta A, van Lijnschoten I, Framery B, Pelegrin A, Gutowski M, Nienhuijs SW, de Hingh IHJT, Nieuwenhuijzen GAP, Rutten HJT, Cailler F, Burggraaf J, Vahrmeijer AL. Safety and effectiveness of SGM-101, a fluorescent antibody targeting carcinoembryonic antigen, for intraoperative detection of colorectal cancer: a dose-escalation pilot study. Lancet Gastroenterol Hepatol. 2018 Mar;3(3):181-191. doi: 10.1016/S2468-1253(17)30395-3. Epub 2018 Jan 30.

    PMID: 29361435DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsPancreatic NeoplasmsColorectal NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Alexander L Vahrmeijer, MD, PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 25, 2016

Study Start

January 1, 2016

Primary Completion

April 15, 2019

Study Completion

May 1, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(3)