NCT04642924

SGM-101 in Locally Advanced and Recurrent Rectal Cancer

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 203 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• Recurrent Rectal Cancer

Interventions

Type	Name	Description
DRUG	SGM-101	Fluorescence-guided surgery

Timeline

• Start date: 2019-10-22
• Primary completion: 2021-10-01
• Completion: 2023-10-01
• First posted: 2020-11-24
• Last updated: 2020-11-24

Locations

4 sites across 1 country: Netherlands