Rectal NeoplasmsPhase 2SGM-CBMNCT04755920
SGM-101 in Colorectal Brain Metastases.
A Phase 2 study testing SGM-101 in people with Rectal Neoplasms and Rectum Cancer, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms, Rectum Cancer, Colorectal Neoplasms
- 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 Jan 2024to Feb 2026
- 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 brain metastasis of colorectal origin and scheduled for a resection.
Who cannot join
- History of any anaphylactic reaction;
- Previous use of SGM-101;
- 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;
Show all 12Show fewer
- Serum creatinine above 1.5 times the ULN 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;
- Patients pregnant or breastfeeding;
- Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333 ZA
Alexander Vahrmeijer, MD, PhD
- Recruiting
Medical Center Haaglanden
The Hague, 2512 VA
Marike Broekman, MD, PhD
About this study
Official title: A Feasibility Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Colorectal Brain Metastases.
This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.
- Conditions
- Rectal Neoplasms, Rectum Cancer, Colorectal Neoplasms, Brain Metastases, Brain Neoplasms, Brain Diseases
- Being tested
- SGM-101
- Medical subject headings
- Rectal Neoplasms, Colorectal Neoplasms, Brain Neoplasms, Brain Diseases, Intestinal Neoplasms, Gastrointestinal Neoplasms, Gastrointestinal Diseases, Intestinal Diseases
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 |
|---|---|---|
| Patients with colorectal brain metastases | Experimental | 10 mg SGM-101, administration 3 to 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.
To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.
- Concordance between the fluorescent signal and the tumor status (incl. degree of CEA-expression) of resected tissue;
- Concordance between the fluorescent signal and the resection margin with the use of neuronavigation
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Jan 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Center Haaglanden, Surgimab
- Responsible party
- Principal investigator, Alexander Vahrmeijer, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755920
- Sponsor's protocol ID
- NL74956.058.20
- Acronym
- SGM-CBM
- Status last verified
- May 2024
- First submitted
- 27 Jan 2021
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Colorectal Brain Metastases.
- ClinicalTrials.gov ID
- NCT04755920
- Acronym / sponsor ID
- SGM-CBM / NL74956.058.20
- Conditions
- Rectal Neoplasms, Rectum Cancer, Colorectal Neoplasms, Brain Metastases, Brain Neoplasms, Brain Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Medical Center Haaglanden, Surgimab
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 16 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.
This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal brain metastases | Experimental | Drug: SGM-10110 mg SGM-101, administration 3 to 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 brain metastasis of colorectal origin and scheduled for a resection.
Key exclusion criteria (12 listed)
- History of any anaphylactic reaction;
- Previous use of SGM-101;
- 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;
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 | Patients with colorectal brain metastases |
Primary outcome
To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.
Time frame: Intraoperative
* Concordance between the fluorescent signal and the tumor status (incl. degree of CEA-expression) of resected tissue; * Concordance between the fluorescent signal and the resection margin with the use of neuronavigation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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. 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 Rectal Neoplasms and Rectum 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 9 May 2024. 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 Mats Warmerdam, MD (+31 71 5265 401, m.i.warmerdam@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases. (time frame: Intraoperative). 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 9 May 2024.