The agent is an antibody-based fluorescence-guided approach aimed at improving surgery and clinical outcomes.
France-based SurgiMab has recruited its first U.S. patient for a Phase III trial evaluating its investigational imaging agent SGM-101 in patients undergoing colorectal cancer (CRC) surgery. The agent is an antibody-based fluorescence-guided approach aimed at improving surgery and clinical outcomes.
For its Phase III trial, the company is looking to recruit 300 colorectal cancer patients in 10 centers across the United States and Europe. The trial will assess the safety and clinical benefit of using fluorescence-guided surgery with SGM-101 as an intraoperative imaging agent.
The hope is that SGM-101 will be able to help surgeons better identify cancerous lesions. SGM-101 is a tumor-specific antibody conjugated to a dye (fluorophore) that fluoresces under near-infrared light. Four days before a patient is expected to undergo colorectal cancer surgery, the patient will be injected with 10 mg of SGM-101. The agent will then target biomarkers on the cancer cell surface called carcinoembryonic antigen (CEA). CEA is overexpressed by more than 95% of colorectal cancer cells, SurgiMab said. During the surgery, SGM-101 should improve the visualization of tumor tissues overexpressing CEA in real-time.
The Phase III trial will determine how well SGM-101 works in that real-time setting. The trial will reveal if SGM-101 can clearly delineate the margin between tumor tissue and healthy tissue. If that’s the case, SurgiMab said it will allow “a more accurate and complete resection of tumor tissue beyond what can currently be achieved with standard procedures.”
“If this Phase III trial successfully demonstrates that the use of SGM-101 improves tumor resection, we believe that this could provide a new approach for the close to 150,000 patients diagnosed with CRC every year in the United States, most of whom undergo surgery,” SurgiMab Chief Executive Officer Francoise Cailler said in a statement.
In a Phase II trial, SGM-101 demonstrated its ability to detect residual and otherwise invisible tumor tissue during surgery. Data from the Phase II study, which was published in The Lancet Gastroenterology & Hepatology, showed that the use of SGM-101 during surgery leads to a modification of surgery in 35% of patients with recurrent or peritoneal metastases of CRC by allowing either more aggressive resection of tumor tissue or by preserving healthy tissue.
In addition to determining if the fluorescent agency can boost surgical outcomes, the III trial is also seeking to determine if the use of SGM-101 could minimize or prevent removal of healthy tissue adjacent to tumor cells in order to better preserve functional outcomes.
Preliminary results from the Phase III trial are expected in 2020.
