NCT06934538RecruitingPhase 1/2
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)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 16 May 2024
- Start date
- 17 Jun 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- Brenus Pharma
- Diseases
- Colorectal cancer
- NCT number
- NCT06934538
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 90
- From 17 Jun 2025 to the primary completion date, Jun 2028
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Resectable tumor with curative intent or patient considered for a curative strategy by intensifying chemotherapy to induce resectability
- Prior chemotherapy for metastatic disease
- Prior immunotherapy for advanced/metastatic disease (except for Arm 2A-2)
- Prior therapy with an investigational agent
- Major surgery \<4 weeks prior to first administration of STC-1010
- Radiotherapy \< 4 weeks prior to first administration of STC-1010 or \< 2 weeks in case of palliative radiotherapy
- Prior stem cell or solid organ transplantation
- Active drug or alcohol abuse as assessed by the Investigator
Other illness
- Active auto-immune diseases such as rheumatoid arthritis, lupus, Crohn's disease, ulcerative colitis
- Medical conditions requiring immunosuppressive therapy
- Dementia or altered mental status or subject of a legal protection measure that would prohibit informed consent
- Participant deprived of their liberty by a judicial or administrative decision, undergoing psychiatric care and admitted to a health or social establishment for purposes other than research.
Other
- Patients with symptomatic ascites or pleural effusion
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- BRAF mutation
Who the study is looking for
- Male or female aged 18-75 years
- Histologically confirmed diagnosis of unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) (R0) adenocarcinoma of the colon or rectum
- Adjuvant fluoropyrimidine monotherapy or oxaliplatin-based chemotherapy allowed if more than 6 months have elapsed between the end of adjuvant treatment and first relapse
- Determination of KRAS and BRAF mutation status
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Must agree to have biopsy at screening and on-treatment, only if not representing an unacceptable clinical risk and/or if technically feasible as judged by the Investigator in discussion with the interventional radiologist or endoscopist
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. Participants \>70 years must have a PS= 0.
- Life expectancy \> 3 months as assessed by the investigator
- Effective contraceptive measures implemented
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Georges-François Leclerc (CGFL) Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Léon Berard (CLB) Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hospices Civils de Lyon HCL Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut du Cancer de Montpellier (ICM) Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers (CHU) Coordinator of this site? Confirm its status | Poitiers | France | Not yet recruiting |
| Institut Gustave Roussy (IGR) Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.