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First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
Sponsor: Brenus Pharma
Summary
This is a phase I/IIA, first-in-human (FIH), two-part, open-label, multicenter study to characterize the safety, tolerability profile, and clinical efficacy of STC-1010 associated with GM-CSF and cyclophosphamide immunostimulant (IS) regimen administered with standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab) to participants with unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) colorectal cancer (CRC). The trial will be conducted in two parts: * A Phase I consisting of a dose escalation part and small expansion part to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D) and safety profile of the STC-1010 + IS regimen administered with SOC therapy. Approximately 21 to 33 participants will be included in this phase in Europe. * A Phase IIA consisting of the expansion stage of the study which will further evaluate the clinical efficacy and safety of STC-1010 on a larger number of participants treated at the identified RP2D. Approximately 57 to 60 participants will be enrolled in total in 2 different arms. Multi-site recruitment will take place in Europe and in the US.
Official title: Open Label, Multicenter, Dose-escalation and Cohort-expansion Phase I/IIA Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer (CRC) - BreAK CRC Trial (BreAK for Brenus Anti-cancer)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-06-17
Completion Date
2029-06
Last Updated
2025-12-22
Healthy Volunteers
No
Interventions
STC-1010 + IS regimen + SOC therapy
STC-1010 administered with immunostimulants (IS) in low-dose (cyclophosphamide and GM-CSF) and standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab)
Locations (9)
Johns Hopkins
Baltimore, Maryland, United States
Institut Jules Bordet
Brussels, Belgium
Institut Bergonié
Bordeaux, France
Centre Georges François Leclerc (CGFL)
Dijon, France
Centre Léon Bérard (CLB)
Lyon, France
Hospices Civils de Lyon (HCL)
Lyon, France
Institut du Cancer de Montpellier (ICM)
Montpellier, France
Centre Hospitalier Universitaire de Poitiers (CHU)
Poitiers, France
Institut Gustave Roussy (IGR)
Villejuif, France