Colorectal CancerPhase 2SGM-CLMNCT04737213
SGM-101 in Colorectal Lung Metastases
A Phase 2 study testing SGM-101 in people with Colorectal Cancer and Metastatic Colon Cancer, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
Near-infrared fluorescence-guided oncologic surgery (FGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness. SGM-101 already proven to be safe and valuable in colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastatic Colon Cancer
- What is being tested?
- SGM-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Nov 2020to 1 Dec 2021
- Phase
- Phase 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
- Signed informed consent prior to any study-mandated procedure;
- Patients aged over 18 years old;
- All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
- Diagnosed with lung metastasis of colorectal origin and scheduled for a resection.
Who cannot join
- History of any anaphylactic reaction;
- 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;
- Laboratory abnormalities defined as:
- Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
- Total bilirubin above 2 times the ULN or;
- Serum creatinine above 1.5 times the ULN or;
Show all 12Show fewer
- 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;
- Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
- Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
- Previous SGM-101 use
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Ruben Meijer, MD, +31 71 526 9111, r.p.j.meijer@lumc.nl
Robin Faber, r.a.faber@lumc.nl
- Not yet recruiting
Erasmus Medical Center
Rotterdam
Hidde Galema, +31 10 704 0704
About this study
Official title: An Open-label, Exploratory Study Assessing the Feasibility of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Lung Metastasis in Colorectal Cancer
Near-infrared fluorescence-guided oncologic surgery (FGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness. SGM-101 already proven to be safe and valuable in colorectal cancer.
This study aims to prove feasibility for colorectal lung metastases.
- Conditions
- Colorectal Cancer, Metastatic Colon Cancer
- Being tested
- SGM-101
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGM-101Drug
Fluorescence guided surgery
| Study group | Role | What they receive |
|---|---|---|
| SGM-101 | Experimental | Patients included with colorectal lung metastases, SGM-101 7.5-12.5mg, 3-5 days prior to surgery Receives: Drug: SGM-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of SGM-101 and a near-infrared camera system to detect colorectal lung metastases.
Intraoperative imaging of colorectal lung metastases based on the tumor-to-background ratio
Measured: peroperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective inclusion patients with colorectal lung metastases. Al injected with SGM-101.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Surgimab
- Responsible party
- Principal investigator, Alexander Vahrmeijer, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737213
- Sponsor's protocol ID
- P19.101
- Acronym
- SGM-CLM
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meijer RPJ, Galema HA, Faber RA, Bijlstra OD, Maat APWM, Cailler F, Braun J, Keereweer S, Hilling DE, Burggraaf J, Vahrmeijer AL, Hutteman M; SGM-CLM study group. Intraoperative molecular imaging of colorectal lung metastases with SGM-101: a feasibility study. Eur J Nucl Med Mol Imaging. 2024 Aug;51(10):2970-2979. doi: 10.1007/s00259-023-06365-3. Epub 2023 Aug 8.
PubMed 37552367
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Exploratory Study Assessing the Feasibility of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Lung Metastasis in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04737213
- Acronym / sponsor ID
- SGM-CLM / P19.101
- Conditions
- Colorectal Cancer, Metastatic Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Surgimab
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 3 Feb 2021 (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.
Near-infrared fluorescence-guided oncologic surgery (FGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness. SGM-101 already proven to be safe and valuable in colorectal cancer.
This study aims to prove feasibility for colorectal lung metastases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective inclusion patients with colorectal lung metastases. Al injected with SGM-101.
| Arm | Type | Receives |
|---|---|---|
| SGM-101 | Experimental | Drug: SGM-101Patients included with colorectal lung metastases, SGM-101 7.5-12.5mg, 3-5 days prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent prior to any study-mandated procedure;
- Patients aged over 18 years old;
- All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
- Diagnosed with lung metastasis of colorectal origin and scheduled for a resection.
Key exclusion criteria (12 listed)
- History of any anaphylactic reaction;
- 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;
- Laboratory abnormalities defined as:
- Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
- 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-101Fluorescence guided surgery | Drug | SGM-101 |
Primary outcome
Ability of SGM-101 and a near-infrared camera system to detect colorectal lung metastases.
Time frame: peroperative
Intraoperative imaging of colorectal lung metastases based on the tumor-to-background ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Derived from this study: PubMed 37552367Meijer RPJ, Galema HA, Faber RA, Bijlstra OD, Maat APWM, Cailler F, Braun J, Keereweer S, Hilling DE, Burggraaf J, Vahrmeijer AL, Hutteman M; SGM-CLM study group. Intraoperative molecular imaging of colorectal lung metastases with SGM-101: a feasibility study. Eur J Nucl Med Mol Imaging. 2024 Aug;51(10):2970-2979. doi: 10.1007/s00259-023-06365-3. Epub 2023 Aug 8.
- 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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGM-101 in people with Colorectal Cancer and Metastatic Colon Cancer, run by Leiden University Medical Center at 2 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 12 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Vahrmeijer (071 526 9111, a.l.vahrmeijer@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of SGM-101 and a near-infrared camera system to detect colorectal lung metastases. (time frame: peroperative). 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 NCT04737213, which also lists 1 linked publication.
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 3 Feb 2021.