Tests STC-1010 immunotherapy with chemotherapy in advanced colorectal cancer
Tests STC-1010 immunotherapy alongside standard treatment in adults with advanced colorectal cancer.
Key facts
- Who runs it
- Brenus Pharma
- Where
- Bordeaux, Dijon, Lyon, Montpellier, Poitiers, and Villejuif, FranceSee the 7 sitesAlso in 2 other countries, 2 sites
- Trial code
- Registry title
- First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 90 people, planned
- Started
- 17 Jun 2025
- Expected to end
- Jun 2029
- Type of study
- Interventional, 3 groups
- Treatments tested
- STC-1010 + IS regimen + SOC therapy
- Record updated
- 20 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with colon or rectal cancer that cannot be removed by surgery and is either locally advanced or has spread. It tests a new immunotherapy, STC-1010, together with standard chemotherapy.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Adenocarcinoma of the colon or rectum that cannot be removed by surgery: locally advanced (stage IIIC, T4b) or metastatic (stage IV). The disease must be measurable on scans (RECIST 1.1).
- Earlier treatment
- No chemotherapy before for metastatic disease. Earlier adjuvant fluoropyrimidine alone or oxaliplatin-based chemotherapy is allowed only if more than 6 months passed between its end and the first relapse. No earlier immunotherapy for advanced or metastatic disease (except in Arm 2A-2). No earlier investigational drug.
- Biomarker or test result
- KRAS and BRAF mutation status must be determined. People with a BRAF mutation cannot join.
Main reasons for not taking part
- BRAF mutation
- Active autoimmune disease such as rheumatoid arthritis, lupus, Crohn's disease or ulcerative colitis
- A medical condition that needs immunosuppressive therapy
- Earlier stem cell or solid organ transplant
- Dihydropyrimidine dehydrogenase (DPD) deficiency
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Patients with symptomatic ascites or pleural effusion
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- BRAF mutation
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in France
Also in 2 other countries, 2 sites
- Institut BergonieBordeaux, FranceContact: Antoine Italiano, M.D, Ph.DTaking people
- Centre Georges-François Leclerc (CGFL)Dijon, FranceContact: François GHIRINGHELLI, MD, Ph.DTaking people
- Centre Léon Berard (CLB)Lyon, FranceContact: Philippe Cassier, M.DTaking people
- Hospices Civils de Lyon HCLLyon, FranceContact: Benoit You, M.D, Ph.DTaking people
- Institut du Cancer de Montpellier (ICM)Montpellier, FranceContact: Diego Tosi, M.DTaking people
- Centre Hospitalier Universitaire de Poitiers (CHU)Poitiers, FranceContact: David Tougeron, M.D, Ph.DNot yet recruiting
- Institut Gustave Roussy (IGR)Villejuif, FranceContact: Antoine Hollebecque, M.DTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The 3 groups in the trial
- Phase 1Treatment being tested
Dose-escalation and small expansion study in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with microsatellite stable (MSS) disease who have not received prior treatment
Treatment: STC-1010 + IS regimen + SOC therapy
- Phase 2A: Arm 2A-1Treatment being tested
Evaluation of safety and efficacy in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with MSS disease
Treatment: STC-1010 + IS regimen + SOC therapy
- Phase 2A: Arm 2A-2Treatment being tested
Evaluation of safety and efficacy in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with microsatellite instability-high (MSI-H) disease
Treatment: STC-1010 + IS regimen + SOC therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Plain-language title
- Tests STC-1010 immunotherapy with chemotherapy in advanced colorectal cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06934538, who can take part
- Record updated
- 20 October 2026