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RECRUITING
NCT06934538
PHASE1/PHASE2

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

Sponsor: Brenus Pharma

View on ClinicalTrials.gov

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

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)

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