SGM-LARRC: SGM-101 in Locally Advanced and Recurrent Rectal Cancer

• Sponsor: Leiden University Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04642924
• Collaborator: Erasmus Medical Center (Other), Amsterdam UMC, location VUmc (Other), Catharina Ziekenhuis Eindhoven (Other), Medical Center Haaglanden (Other), Surgimab (Industry), Quest Medical Imaging (Other), Centre for Human Drug Research, Netherlands (Other)
• Enrollment: 203
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 47.3
• Patients Per Site: 50.8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer; Recurrent Rectal Cancer	Drug: SGM-101	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 203 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospectively inclusion treatment arm. Compared to historical cohort.Prospectively inclusion treatment arm. Compared to historical cohort.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 22, 2019
• Anticipated Primary Completion Date: Oct 1, 2021
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Locally Advanced Rectal Cancer Patients included with locally advanced rectal cancer SGM-101 10mg, 3-5 days prior to surgery	Drug: SGM-101; Fluorescence-guided surgery
Experimental: Recurrent rectal cancer Patients included with (locally) recurrent rectal cancer SGM-101 10mg, 3-5 days prior to surgery	Drug: SGM-101; Fluorescence-guided surgery

Outcome Measures

Primary Outcome Measures

1. Resection status [10 days post surgery]

   Pathologic resection status (R0 or R1)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Patients aged over 18 years old;

2. 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.

3. 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)

4. Patients should be capable and willing to give signed informed consent before study specific procedures.

Exclusion Criteria:

1. 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.

2. Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery)

3. Patients with a recent history (within the last 3 years) of other distant metastases (even those diagnosed during surgery)

4. Patient with a history of a clinically significant allergy.

5. Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential;

6. Laboratory abnormalities defined as:

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

8. Total bilirubin above 2 times the ULN or;

9. Serum creatinine above 1.5 times the ULN or;

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

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

12. 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;

13. Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives.

14. Previous administration of SGM-101

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amsterdam University Medical Center	Amsterdam		Netherlands
2	Haaglanden Medisch Centrum	Den Haag		Netherlands
3	Catharina Hospital Eindhoven	Eindhoven		Netherlands
4	Erasmus Medical Center	Rotterdam		Netherlands

Sponsors and Collaborators

• Leiden University Medical Center
• Erasmus Medical Center
• Amsterdam UMC, location VUmc
• Catharina Ziekenhuis Eindhoven
• Medical Center Haaglanden
• Surgimab
• Quest Medical Imaging
• Centre for Human Drug Research, Netherlands

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: NCT04642924
• Other Study ID Numbers: L19-069
• First Posted: Nov 24, 2020
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 1, 2020

• 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
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Rectal Neoplasms; Recurrence

Study Results

No Results Posted as of Nov 24, 2020