First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
NCT ID: NCT06934538
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2025-06-17
2029-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1
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
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)
Phase 2A: Arm 2A-1
Evaluation of safety and efficacy in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with MSS disease
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)
Phase 2A: Arm 2A-2
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
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Histologically confirmed diagnosis of unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) (R0) adenocarcinoma of the colon or rectum
3. Adjuvant fluoropyrimidine monotherapy or oxaliplatin-based chemotherapy allowed if more than 6 months have elapsed between the end of adjuvant treatment and first relapse
4. Determination of KRAS and BRAF mutation status
5. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
6. 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
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. Participants \>70 years must have a PS= 0.
8. Life expectancy \> 3 months as assessed by the investigator
9. Effective contraceptive measures implemented
Exclusion Criteria
2. Dihydropyrimidine dehydrogenase (DPD) deficiency
3. Resectable tumor with curative intent or patient considered for a curative strategy by intensifying chemotherapy to induce resectability
4. Prior chemotherapy for metastatic disease
5. Prior immunotherapy for advanced/metastatic disease (except for Arm 2A-2)
6. Prior therapy with an investigational agent
7. BRAF mutation
8. Active auto-immune diseases such as rheumatoid arthritis, lupus, Crohn's disease, ulcerative colitis
9. Medical conditions requiring immunosuppressive therapy
10. Major surgery \<4 weeks prior to first administration of STC-1010
11. Radiotherapy \< 4 weeks prior to first administration of STC-1010 or \< 2 weeks in case of palliative radiotherapy
12. Prior stem cell or solid organ transplantation
13. Dementia or altered mental status or subject of a legal protection measure that would prohibit informed consent
14. Active drug or alcohol abuse as assessed by the Investigator
15. 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brenus Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Eric Christenson, MD
Role: primary
Francesco Sclafani, M.D
Role: primary
Antoine Italiano, M.D, Ph.D
Role: primary
François GHIRINGHELLI, MD, Ph.D
Role: primary
Philippe Cassier, M.D
Role: primary
Benoit You, M.D, Ph.D
Role: primary
Diego Tosi, M.D
Role: primary
David Tougeron, M.D, Ph.D
Role: primary
Antoine Hollebecque, M.D
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BreAK CRC-001
Identifier Type: -
Identifier Source: org_study_id