SGM-101 in Locally Advanced and Recurrent Rectal Cancer (SGM-LARRC)

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Recurrent Rectal Cancer
• Intervention / Treatment: Drug: SGM-101

• Study Type: Interventional
• Enrollment (Anticipated): 203
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ruben Meijer; Phone Number: +31 71-52 98420; Email: r.p.j.meijer@lumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam University Medical Center
    • Contact: Miranda Kusters
  • Den Haag, Netherlands
    • Not yet recruiting
    • Haaglanden Medisch Centrum
    • Contact: Andreas Marinelli
  • Eindhoven, Netherlands
    • Recruiting
    • Catharina Hospital Eindhoven
    • Contact: Harm Rutten
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus Medical Center
    • Contact: Kees Verhoef; Phone Number: +31 10 704 0704

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

   1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
   2. Total bilirubin above 2 times the ULN or;
   3. Serum creatinine above 1.5 times the ULN or;
   4. Platelet count below 100 x 109/L or;
   5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
   6. 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;
7. Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives.
8. Previous administration of SGM-101

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resection status	Pathologic resection status (R0 or R1)	10 days post surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 22, 2019
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (ACTUAL): November 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence; Rectal Neoplasms
• Other Study ID Numbers: L19-069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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