Colorectal NeoplasmsPhase 3NCT03659448
Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
A Phase 3 study testing SGM-101 in people with Colorectal Neoplasms, run by Surgimab at 11 sites in 4 countries.
Trial summary
The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- SGM-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 17 Jun 2019to Dec 2024
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer.
- Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection.
Who cannot join
- Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
- Primary appendiceal cancer;
- Laboratory abnormalities defined as:
- Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
- Total bilirubin above 2 times the ULN or;
- Serum creatinine above 1.5 times the ULN or;
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- 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 patient's well-being or the study objectives.
Trial locations and contacts
11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 4 countries
United States6 sites, 6 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rocco Ricciardi, MD, RRICCIARDI1@mgh.harvard.edu
Caitlin Stafford, 617-643-7869, CSTAFFORD2@partners.org
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
Thinzar Lwin, MD, MS, 626-613-6032, tlwin@coh.org
Thinzar Lwin, MD, MS
- Recruiting
Moores Cancer Center - UCSD Health
La Jolla, California, 92093
Sonia L Ramamoorthy, MD, 858-657-6100, sramamoorthy@ucsd.edu
Dad Shakeela, Ph.D., (858) 822-5376, sdad@ucsd.edu
- Recruiting
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Sunil Singhal, MD, Sunil.Singhal@uphs.upenn.edu
Najjia Mahmoud, MD
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
David J MARON, MD, 954-659-5278, MAROND@ccf.org
Maria MEJIA, BS, CCRP, (954) 659-5888, MEJIAGM@ccf.org
- Recruiting
University of Massachusetts
Worcester, Massachusetts, 01655
Sharon Balcom, RN, 508-334-4918, Sharon.Balcom@umassmed.edu
Karim Alavi, MD
Netherlands3 sites, 3 recruiting
- Recruiting
Catharina Ziekenhuis Eindhoven
Eindhoven
H J Rutten, MD, PhD, +31 40 2397150, harm.rutten@catharinaziekenhuis.nl
- Recruiting
Leiden University Medical Center
Leiden, 2333 CL
Alexander L Vahrmeijer, MD, Ph.D., +31 71 5262309, a.l.vahrmeijer@lumc.nl
Ruben P Meijer, MD, +31 71 7517143, R.P.J.Meijer@lumc.nl
- Recruiting
Erasmus MC
Rotterdam, 3015
Cornelis Verhoef, MD, c.verhoef@erasmusmc.nl
Job Kooten, MD, j.kooten@erasmusmc.nl
Germany1 site, 1 recruiting
- Recruiting
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
Göttingen, 37075
Jens Sperling, MD, +49 551 39 7989, Jens.Sperling@med.uni-goettingen.de
Johanna Kreutzer, Ph.D., johanna.kreutzer@med.uni-goettingen.de
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Luigi Pugliese, MD, luipugliese@gmail.com
Andrea Pietrabissa, MD
About this study
Official title: Multicenter, Open-label, Randomized, Controlled, Parallel Arms Clinical Study on Performance of SGM-101, a Fluorochrome-labeled Anti-CEA Monoclonal Antibody, for Delineation of Primary/Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.
Read the detailed description
The performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer will be compared to that of standard "white light" visualization in a multicenter, open-label, randomized, controlled, parallel arms clinical study.
- Conditions
- Colorectal Neoplasms
- Being tested
- SGM-101
- Keywords
- Fluorescence, Cancer, SGM-101, Surgery, Colorectal
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGM-101Drug
A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Patients will receive a single dose of the study drug, SGM-101, and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR. Receives: Drug: SGM-101 |
| No Treatment | No intervention | Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical resection histopathology.
Comparison of surgical resections using histopathology as standard of truth..
Measured: Through completion of surgery, up to 9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start17 Jun 2019
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms consisting of a treatment arm of patients who will receive the study drug and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR, and a no treatment arm to whom the study drug will not be administered and who will undergo surgical resections under standard "white light" conditions only.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surgimab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex L. Vahrmeijer,, MD, PhD, Principal investigator, Leiden University Medical Center, Leiden, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659448
- Sponsor's protocol ID
- SGM-CLIN03
- Status last verified
- Apr 2024
- First submitted
- 4 May 2018
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Randomized, Controlled, Parallel Arms Clinical Study on Performance of SGM-101, a Fluorochrome-labeled Anti-CEA Monoclonal Antibody, for Delineation of Primary/Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03659448
- Acronym / sponsor ID
- SGM-CLIN03
- Conditions
- Colorectal Neoplasms
- Keywords
- Fluorescence, Cancer, SGM-101, Surgery, Colorectal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- SurgimabIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.
Detailed description
The performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer will be compared to that of standard "white light" visualization in a multicenter, open-label, randomized, controlled, parallel arms clinical study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel arms consisting of a treatment arm of patients who will receive the study drug and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR, and a no treatment arm to whom the study drug will not be administered and who will undergo surgical resections under standard "white light" conditions only.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: SGM-101Patients will receive a single dose of the study drug, SGM-101, and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR. |
| No Treatment | No intervention | –Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer.
- Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection.
Key exclusion criteria (11 listed)
- Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
- Primary appendiceal cancer;
- Laboratory abnormalities defined as:
- 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 patient's well-being or the study objectives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGM-101A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent. | Drug | Treatment |
Primary outcome
Surgical resection histopathology.
Time frame: Through completion of surgery, up to 9 weeks.
Comparison of surgical resections using histopathology as standard of truth..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex L. Vahrmeijer,, MD, PhD principal investigator
Leiden University Medical Center, Leiden, The Netherlands
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SGM-101 in people with Colorectal Neoplasms, run by Surgimab at 11 sites in 4 countries.
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 2 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Netherlands, Germany, Italy. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Warner, JD, MPA (8123257657, johna.warner@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical resection histopathology. (time frame: Through completion of surgery, up to 9 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2024.