SGM-101 in Locally Advanced and Recurrent Rectal Cancer

Rectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04642924
• Other study ID #: L19-069
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 22, 2019
• Est. completion date: October 2023

Study information

• Verified date: November 2020
• Source: Leiden University Medical Center
• Contact: Ruben Meijer
• Phone: +31 71-52 98420
• Email: r.p.j.meijer[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 203
• Est. completion date: October 2023
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Recurrent Rectal Cancer

Intervention

Drug:
• SGM-101
Fluorescence-guided surgery

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center	Amsterdam
Netherlands	Haaglanden Medisch Centrum	Den Haag
Netherlands	Catharina Hospital Eindhoven	Eindhoven
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (8)

Lead Sponsor	Collaborator
Leiden University Medical Center	Catharina Ziekenhuis Eindhoven, Centre for Human Drug Research, Netherlands, Erasmus Medical Center, Medical Center Haaglanden, Quest Medical Imaging, Surgimab, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resection status	Pathologic resection status (R0 or R1)	10 days post surgery