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

Primary Purpose

Rectal Cancer, Recurrent Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
SGM-101
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amsterdam University Medical CenterRecruiting
  • Haaglanden Medisch Centrum
  • Catharina Hospital EindhovenRecruiting
  • Erasmus Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Locally Advanced Rectal Cancer

Recurrent rectal cancer

Arm Description

Patients included with locally advanced rectal cancer SGM-101 10mg, 3-5 days prior to surgery

Patients included with (locally) recurrent rectal cancer SGM-101 10mg, 3-5 days prior to surgery

Outcomes

Primary Outcome Measures

Resection status
Pathologic resection status (R0 or R1)

Secondary Outcome Measures

Full Information

First Posted
November 16, 2020
Last Updated
November 23, 2020
Sponsor
Leiden University Medical Center
Collaborators
Erasmus Medical Center, Amsterdam UMC, location VUmc, Catharina Ziekenhuis Eindhoven, Medical Center Haaglanden, Surgimab, Quest Medical Imaging, Centre for Human Drug Research, Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT04642924
Brief Title
SGM-101 in Locally Advanced and Recurrent Rectal Cancer
Acronym
SGM-LARRC
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Erasmus Medical Center, Amsterdam UMC, location VUmc, Catharina Ziekenhuis Eindhoven, Medical Center Haaglanden, Surgimab, Quest Medical Imaging, Centre for Human Drug Research, Netherlands

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Recurrent Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospectively inclusion treatment arm. Compared to historical cohort.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
203 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Locally Advanced Rectal Cancer
Arm Type
Experimental
Arm Description
Patients included with locally advanced rectal cancer SGM-101 10mg, 3-5 days prior to surgery
Arm Title
Recurrent rectal cancer
Arm Type
Experimental
Arm Description
Patients included with (locally) recurrent rectal cancer SGM-101 10mg, 3-5 days prior to surgery
Intervention Type
Drug
Intervention Name(s)
SGM-101
Intervention Description
Fluorescence-guided surgery
Primary Outcome Measure Information:
Title
Resection status
Description
Pathologic resection status (R0 or R1)
Time Frame
10 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruben Meijer
Phone
+31 71-52 98420
Email
r.p.j.meijer@lumc.nl
Facility Information:
Facility Name
Amsterdam University Medical Center
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda Kusters
Facility Name
Haaglanden Medisch Centrum
City
Den Haag
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Marinelli
Facility Name
Catharina Hospital Eindhoven
City
Eindhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harm Rutten
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kees Verhoef
Phone
+31 10 704 0704

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SGM-101 in Locally Advanced and Recurrent Rectal Cancer

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