NCT06934538

First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Brenus Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unresectable Metastatic Colorectal Cancer
• Unresectable Locally Advanced Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	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)

Timeline

• Start date: 2025-06-17
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2025-04-18
• Last updated: 2025-12-22

Locations

9 sites across 3 countries: United States, Belgium, France

Regulatory

• FDA-regulated drug study