SGM-CLM: SGM-101 in Colorectal Lung Metastases

• Sponsor: Leiden University Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04737213
• Collaborator: Erasmus Medical Center (Other), Surgimab (Industry)
• Enrollment: 10
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 13
• Patients Per Site: 5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

This study aims to prove feasibility for colorectal lung metastases.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Metastatic Colon Cancer	Drug: SGM-101	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective inclusion patients with colorectal lung metastases. Al injected with SGM-101.Prospective inclusion patients with colorectal lung metastases. Al injected with SGM-101.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Nov 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGM-101 Patients included with colorectal lung metastases, SGM-101 7.5-12.5mg, 3-5 days prior to surgery	Drug: SGM-101; Fluorescence guided surgery

Outcome Measures

Primary Outcome Measures

1. Ability of SGM-101 and a near-infrared camera system to detect colorectal lung metastases. [peroperative]

   Intraoperative imaging of colorectal lung metastases based on the tumor-to-background ratio

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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 lung metastasis of colorectal origin and scheduled for a resection.

Exclusion Criteria:

1. History of any anaphylactic reaction;

2. 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;

3. Laboratory abnormalities defined as:

4. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;

5. Total bilirubin above 2 times the ULN or;

6. Serum creatinine above 1.5 times the ULN or;

7. Platelet count below 100 x 109/L or;

8. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);

9. 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;

10. Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);

11. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

12. Previous SGM-101 use

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leiden University Medical Center	Leiden	Zuid-Holland	Netherlands	2333 ZA
2	Erasmus Medical Center	Rotterdam		Netherlands

Sponsors and Collaborators

• Leiden University Medical Center
• Erasmus Medical Center
• Surgimab

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexander Vahrmeijer, Principal Investigator, Leiden University Medical Center
• ClinicalTrials.gov Identifier: NCT04737213
• Other Study ID Numbers: P19.101
• First Posted: Feb 3, 2021
• Last Update Posted: Feb 3, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Feb 3, 2021