A feasibility study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for the intraoperative detection of colorectal brain metastases.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Academisch Ziekenhuis Leiden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

4 Dec 2023 → ongoing

Decision date (initial)

2024-10-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-510767-30-00

EudraCT number

2020-003804-15

ClinicalTrials.gov

NCT04755920

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Dose response, Diagnosis, Therapy

To assess the performance of SGM-101 in the intraoperative detection of brain metastases of colorectal origin.

Secondary objectives 4

1. 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.
2. To assess the number of intraoperative changes in surgical plan based on fluorescence - To assess the relationship between intraoperative changes and pathological status of the resected tissue.
3. To determine the Tumor-to-background ratio (TBR).
4. To determine the tolerability and safety of SGM-101.

Conditions and MedDRA coding

Brain metastases

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Signed informed consent prior to any study-mandated procedure.
2. Patients aged over 18 years old.
3. 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.
4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
5. Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.

Exclusion criteria 5

1. History of any anaphylactic reaction; 7. Previous use of SGM-101.
2. Previous use of SGM-101.
3. 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.
4. Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate).
5. Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Based upon the primary objective: “To assess the performance of SGM-101 in the intraoperative detection of brain metastases of colorectal origin” we propose the following primary endpoint: Concordance rate between the pathology results with respect to the presence of cancer and the imaging assessment. This endpoint is chosen as this study serves as a proof of principle.

Secondary endpoints 4

1. Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology in terms of both CEA expression and tumor status.
2. Modification of operative plan due to imaging (e.g. extension, reduction of resection margins, or additional resection) and change in postoperative treatment will be recorded.
3. Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue.
4. - Treatment-emergent (serious) adverse events ((S)AEs). - Concomitant medication - Vital signs o Pulse Rate (bpm) o Systolic blood pressure (mmHg) o Diastolic blood pressure (mmHg) o Body temperature o Glasgow Coma Scale o Monitoring of unpredicted seizures o Monitoring of unpredicted focal deficits

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Academisch Ziekenhuis Leiden

Sponsor organisation

Academisch Ziekenhuis Leiden

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Clinical Research Center, Department of Surgery

Public contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Clinical Research Center, Department of Surgery

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications