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Colon CancerPhase 1/2NCT02973672

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

A Phase 1/2 study testing SGM-101 in people with Colon Cancer and Rectum Cancer, run by Surgimab at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer, Rectum Cancer, Pancreas Cancer
What is being tested?
SGM-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
3 sitesNetherlands
Study dates
Jan 2016to May 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 15Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Catharina Ziekenhuis Eindhoven

    Eindhoven

  • Leiden University Medical Center

    Leiden, 2333 CL

  • Erasmus Medical Center Cancer Institute

    Rotterdam

Other trials in Netherlands

About this study

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

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.

Read the detailed description

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.

Being tested
SGM-101
Keywords
Fluorescence, Surgery, Cancer, SGM-101, Near Infrared, Immunophotodetection
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGM-101Drug

    Also called SGM 101, SGM101

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

Study groups in NCT02973672
Study groupRoleWhat they receive
SGM-101ExperimentalNot described
Receives: Drug: SGM-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 10 days after the surgery

Secondary outcomes (2)

  1. Tumor-to-background ratio (TBR) for fluorescence

    Measured: day 4

  2. Serum SGM-101 concentrations

    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.

    Measured: up to 1 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2016 (estimated)
  2. Study startJan 2016
  3. Primary completion15 Apr 2019
  4. Study completionMay 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02973672
Sponsor's protocol ID
SGM-CLIN02
Status last verified
Jul 2019
First submitted
16 Nov 2016
Last updated
18 Jul 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 32416765

  • 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.

    PubMed 31960953

  • 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.

    PubMed 29361435

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SGM-101 in people with Colon Cancer and Rectum Cancer, run by Surgimab at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with treatment-related adverse events (time frame: up to 10 days after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02973672, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.

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