Rectal CancerPhase 2/3SGM-LARRCNCT04642924
SGM-101 in Locally Advanced and Recurrent Rectal Cancer
A Phase 2/3 study testing SGM-101 in people with Rectal Cancer and Recurrent Rectal Cancer, run by Leiden University Medical Center at 4 sites in Netherlands.
Trial summary
Near-infrared fluorescence-guided oncologic surgery (EGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness, which can be difficult to detect with conventional visual and tactile feedback. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Recurrent Rectal Cancer
- What is being tested?
- SGM-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 4 sitesNetherlands
- Study dates
- 22 Oct 2019to Oct 2023
- Phase
- Phase 2/3
- 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;
- 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.
- Patients should be scheduled and eligible for surgery because of a clinical diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or recurrent rectal cancer. (UICC. TNM classification of diseases for oncology. 3rd ed. Geneva: World Health Organization; 2000)
- Patients should be capable and willing to give signed informed consent before study specific procedures.
Who cannot join
- Other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
- Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery)
- Patients with a recent history (within the last 3 years) of other distant metastases (even those diagnosed during surgery)
- Patient with a history of a clinically significant allergy.
- Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential;
- Laboratory abnormalities defined as:
Show all 14Show fewer
- 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;
- 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' well-being or the study objectives.
- Previous administration of SGM-101
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites, 4 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam
Miranda Kusters
- Recruiting
Catharina Hospital Eindhoven
Eindhoven
Harm Rutten
- Recruiting
Erasmus Medical Center
Rotterdam
Kees Verhoef, +31 10 704 0704
- Not yet recruiting
Haaglanden Medisch Centrum
The Hague
Andreas Marinelli
About this study
Official title: Multicenter, Open-label, Controlled, Parallel Arms Clinical Study on the Performance of SGM-101, a Fluorochrome-labeled Anti-carcino-embryonic Antigen (CEA) Monoclonal Antibody, for Locally Advanced or Recurrent Rectal Cancer Patients Undergoing Curative Surgery
Near-infrared fluorescence-guided oncologic surgery (EGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness, which can be difficult to detect with conventional visual and tactile feedback. Hence, this information could aid in intra-operative decision making and therewith foster complete resection margins and less extensive surgery. Subsequently, this may drastically improve patient care by improving oncologic outcome.
- Conditions
- Rectal Cancer, Recurrent Rectal Cancer
- Being tested
- SGM-101
- Medical subject headings
- Rectal 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 |
|---|---|---|
| Locally Advanced Rectal Cancer | Experimental | Patients included with locally advanced rectal cancer SGM-101 10mg, 3-5 days prior to surgery Receives: Drug: SGM-101 |
| Recurrent rectal cancer | Experimental | Patients included with (locally) recurrent rectal cancer SGM-101 10mg, 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.
Resection status
Pathologic resection status (R0 or R1)
Measured: 10 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start22 Oct 2019
- Primary completionOct 2021 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospectively inclusion treatment arm. Compared to historical cohort.
- Masking
- None (open label)
- Enrolment
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Amsterdam UMC, location VUmc, Catharina Ziekenhuis Eindhoven, Medical Center Haaglanden, Surgimab, Quest Medical Imaging, Centre for Human Drug Research, Netherlands
- Responsible party
- Principal investigator, Alexander Vahrmeijer, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642924
- Sponsor's protocol ID
- L19-069
- Acronym
- SGM-LARRC
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Controlled, Parallel Arms Clinical Study on the Performance of SGM-101, a Fluorochrome-labeled Anti-carcino-embryonic Antigen (CEA) Monoclonal Antibody, for Locally Advanced or Recurrent Rectal Cancer Patients Undergoing Curative Surgery
- ClinicalTrials.gov ID
- NCT04642924
- Acronym / sponsor ID
- SGM-LARRC / L19-069
- Conditions
- Rectal Cancer, Recurrent Rectal Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Amsterdam UMC, location VUmc, Catharina Ziekenhuis Eindhoven, Medical Center Haaglanden, Surgimab, Quest Medical Imaging, Centre for Human Drug Research, Netherlands
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Nov 2020 (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 (EGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness, which can be difficult to detect with conventional visual and tactile feedback. Hence, this information could aid in intra-operative decision making and therewith foster complete resection margins and less extensive surgery. Subsequently, this may drastically improve patient care by improving oncologic outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospectively inclusion treatment arm. Compared to historical cohort.
| Arm | Type | Receives |
|---|---|---|
| Locally Advanced Rectal Cancer | Experimental | Drug: SGM-101Patients included with locally advanced rectal cancer SGM-101 10mg, 3-5 days prior to surgery |
| Recurrent rectal cancer | Experimental | Drug: SGM-101Patients included with (locally) recurrent rectal cancer SGM-101 10mg, 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 (4 listed)
- 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.
- Patients should be scheduled and eligible for surgery because of a clinical diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or recurrent rectal cancer. (UICC. TNM classification of diseases for oncology. 3rd ed. Geneva: World Health Organization; 2000)
- Patients should be capable and willing to give signed informed consent before study specific procedures.
Key exclusion criteria (14 listed)
- Other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
- Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery)
- Patients with a recent history (within the last 3 years) of other distant metastases (even those diagnosed during surgery)
- Patient with a history of a clinically significant allergy.
- Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential;
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 | Locally Advanced Rectal Cancer, Recurrent rectal cancer |
Primary outcome
Resection status
Time frame: 10 days post surgery
Pathologic resection status (R0 or R1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SGM-101 in people with Rectal Cancer and Recurrent Rectal Cancer, run by Leiden University Medical Center at 4 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 4 inclusion and 14 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruben Meijer (+31 71-52 98420, r.p.j.meijer@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection status (time frame: 10 days post surgery). 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 Nov 2020.