Approved by French regulatory authorities, the trial positions STC-1010 as a potential first-line treatment option for patients with unresectable, locally advanced or metastatic colorectal cancer (stage IIIC or IV)
Brenus Pharma today announced that first patients have been successfully dosed in its first-in-human clinical trial evaluating STC-1010, the company’s lead in vivo immunotherapy candidate developed through its proprietary off-the-shelf platform. Three patients have already been enrolled in the study. The first completed eight weeks of treatment with no adverse events attributed to the investigational therapy. This trial targets patients with unresectable, locally advanced or metastatic colorectal cancer (CRC) — the second leading cause of cancer-related death worldwide — for whom chemotherapy remains the predominant treatment option.
This international “BreAK CRC-001”1 Phase I/IIa, open-label, multicenter trial aims to assess the safety, tolerability, and preliminary efficacy of STC-1010 in over 80 patients in combination with an immunostimulatory regimen (GM-CSF low-dose and cyclophosphamide) and standard-of-care chemotherapy (mFOLFOX6 ± bevacizumab). First results are expected in the first half of 2026.
“This marks a pivotal step for Brenus and the future of new modalities in oncology with the potential to improve outcomes, with more accessible and scalable solution for patients who desperately need it,” said Paul Bravetti, CEO of Brenus Pharma.
“Treating the first patient represents more than a scientific milestone — It’s a profoundly meaningful moment, marking the start of broader clinical and pharmaceutical deployment,” said Benoit Pinteur, co-founder and CSO of Brenus Pharma.
“CRC remains challenging, as current immunotherapies are only effective in dMMR/MSI-H ‘hot’ tumors. For pMMR/MSS patients, there’s a strong need for drugs that can ‘heat up’ cold tumors. BreAK-CRC is eagerly awaited, and we’re excited to explore STC-1010’s potential in first-line combination,” said François Ghiringhelli, M.D., Ph.D., CGFL. Director of early clinical unit and study coordinator.
First sites are already open in France : CGFL, Dijon; Institut Bergonié, Bordeaux; ICM, Montpellier; and HCL, Lyon. Additional centers will open in 2026 in France and Belgium. Further centers will join the study for Phase II with an international U.S. expansion.
About Brenus Pharma
Brenus Pharma develops an off-the-shelf platform advancing novel modalities in immuno-oncology. This cutting-edge precision technology mimics tumor protein expression and makes it visible to the immune system, enabling a multi-specific in vivo immune response against evolving tumor cells.
www.brenus-pharma.com
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“Treating the first patient represents more than a scientific milestone — It’s a profoundly meaningful moment, marking the start of broader clinical and pharmaceutical deployment” said Benoit Pinteur, co-founder and CSO of Brenus Pharma.
