Unresectable Metastatic Colorectal CancerPhase 1/2NCT06934538
First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
A Phase 1/2 study testing STC-1010 + IS regimen + SOC therapy in people with Unresectable Metastatic Colorectal Cancer and Unresectable Locally Advanced Colorectal Cancer, run by Brenus Pharma at 9 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Metastatic Colorectal Cancer, Unresectable Locally Advanced Colorectal Cancer
- What is being tested?
- STC-1010 + IS regimen + SOC therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 17 Jun 2025to Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- Patients with symptomatic ascites or pleural effusion
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- 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
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- BRAF mutation
- Active auto-immune diseases such as rheumatoid arthritis, lupus, Crohn's disease, ulcerative colitis
- Medical conditions requiring immunosuppressive therapy
- 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
- Dementia or altered mental status or subject of a legal protection measure that would prohibit informed consent
- Active drug or alcohol abuse as assessed by the Investigator
- 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.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Sarah KERBOUCHE contact
9 sites in 3 countries
France7 sites, 7 recruiting
- Recruiting
Institut Bergonié
Bordeaux
Antoine Italiano, M.D, Ph.D, A.Italiano@bordeaux.unicancer.fr
- Recruiting
Centre Georges François Leclerc (CGFL)
Dijon
François GHIRINGHELLI, MD, Ph.D, FGhiringhelli@cgfl.fr
- Recruiting
Centre Léon Bérard (CLB)
Lyon
Philippe Cassier, M.D, philippe.cassier@lyon.unicancer.fr
- Recruiting
Hospices Civils de Lyon (HCL)
Lyon
Benoit You, M.D, Ph.D, benoit.you@chu-lyon.fr
- Recruiting
Institut du Cancer de Montpellier (ICM)
Montpellier
Diego Tosi, M.D, Diego.Tosi@icm.unicancer
- Not yet recruiting
Centre Hospitalier Universitaire de Poitiers (CHU)
Poitiers
David Tougeron, M.D, Ph.D, David.tougeron@chu-poitiers.fr
- Recruiting
Institut Gustave Roussy (IGR)
Villejuif
Antoine Hollebecque, M.D, Antoine.hollebecque@gustaveroussy.fr
United States1 site, 1 recruiting
- Not yet recruiting
Johns Hopkins
Baltimore, Maryland, 21287
Eric Christenson, MD, 410-955-8964, echris14@jhmi.edu
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels
Francesco Sclafani, M.D, 003225417397, francesco.sclafani@hubruxelles.be
About this study
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)
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
- Being tested
- STC-1010 + IS regimen + SOC therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STC-1010 + IS regimen + SOC therapyBiological
STC-1010 administered with immunostimulants (IS) in low-dose (cyclophosphamide and GM-CSF) and standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab)
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | 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 Receives: Biological: STC-1010 + IS regimen + SOC therapy |
| Phase 2A: Arm 2A-1 | Experimental | Evaluation of safety and efficacy in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with MSS disease Receives: Biological: STC-1010 + IS regimen + SOC therapy |
| Phase 2A: Arm 2A-2 | Experimental | 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 Receives: Biological: STC-1010 + IS regimen + SOC therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: To determine overall safety profile, recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD)
Endpoint/Outcome Measures:
Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-Limiting Toxicities (DLT) (in dose escalation part), AEs leading to treatment discontinuation; and clinically significant findings on clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examinations, using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
Measured: 28 days
Phase 2A: To determine the clinical efficacy by Progression Free Survival (PFS) rate
Progression Free Survival (PFS) rate at 12 months from STC-1010 + IS regimen initiation, defined as the proportion of participants alive and without progression (i.e., participants with complete response [CR], partial response [PR] or stable disease [SD]) at 12 months according to RECIST 1.1
Measured: 12 months
Secondary outcomes (9)
Phase 1: To determine the preliminary clinical efficacy
Endpoints/Outcome Measures: Overall Response Rate (ORR) at 6 months from STC-1010 + IS treatment initiation, defined as the achievement of either a complete response (CR) or partial response (PR) according to RECIST 1.1; Progression Free Survival (PFS) rate at 6 months from STC-1010 + IS treatment initiation (defined as the rate of participants alive with CR, PR or SD) according to RECIST 1.1; and Median of PFS.
Measured: 6 months
Phase 1: To describe the effects on cell-mediated immunity
Assessment of delayed-type hypersensitivity (DTH) score after the first vaccination (at 1, 24, 48 and 72 hours post-STC-1010 injection) and then after the 4th, 8th and every boost
Measured: Up to 72 hours post injection
Phase 2A: To determine the overall safety and tolerability profile
Endpoints/Outcome Measures: Incidence, severity and relationship of TEAEs, SAEs, TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs and physical examinations, using the CTCAE Version 5.
Measured: 6, 12 and 24 months
Phase 2A: To determine the clinical efficacy by Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) defined as the percentage of participants in whom the best response is CR or PR, or SD lasting for a least 6 months.
Measured: 12 and 24 months
Phase 2A: To determine the clinical efficacy by Objective Response Rate (ORR)
Objective Response Rate (ORR) defined as the proportion of patients who achieve a complete or partial response per RECIST 1.1 criteria. Patients with unevaluable or unknown response status will be considered as non-responders.
Measured: 6, 12 and 24 months
Phase 2A: To determine the clinical efficacy by Duration of Response (DOR)
Duration of response (DOR), defined as the time from first documented evidence of CR or PR to the earliest date of documented radiological progression or death due to any cause
Measured: 6,12 and 24 months
Phase 2A: To determine the clinical efficacy by Progression Free Survival (PFS)
Progression Free Survival (PFS) defined as the time to the date of progression or death from any cause. The median PFS with it's 95% confidence interval (CI) will also be calculated
Measured: 6,12 and 24 months
Phase 2A: To determine the clinical efficacy by Overall Survival (OS)
Overall Survival (OS) defined as the time to the date of death from any cause. The median OS with its 95% CI will also be calculated.
Measured: 12 and 24 months
Phase 2A: To determine the clinical efficacy by metastases resection rate
Metastases resection rate defined as the percentage of participants who undergo resection
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start17 Jun 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brenus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934538
- Sponsor's protocol ID
- BreAK CRC-001
- Status last verified
- Oct 2026
- First submitted
- 16 May 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06934538
- Acronym / sponsor ID
- BreAK CRC-001
- Conditions
- Unresectable Metastatic Colorectal Cancer, Unresectable Locally Advanced Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Brenus PharmaIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Biological: STC-1010 + IS regimen + SOC therapyDose-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 |
| Phase 2A: Arm 2A-1 | Experimental | Biological: STC-1010 + IS regimen + SOC therapyEvaluation of safety and efficacy in BRAF wild type, KRAS mutated, unresectable stage IIIC (T4b) or unresectable stage IV CRC participants with MSS disease |
| Phase 2A: Arm 2A-2 | Experimental | Biological: STC-1010 + IS regimen + SOC therapyEvaluation 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (15 listed)
- Patients with symptomatic ascites or pleural effusion
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STC-1010 + IS regimen + SOC therapySTC-1010 administered with immunostimulants (IS) in low-dose (cyclophosphamide and GM-CSF) and standard of care (SOC) therapy (mFOLFOX6 with or without bevacizumab) | Biological | Phase 1, Phase 2A: Arm 2A-1, Phase 2A: Arm 2A-2 |
Primary outcome
Phase 1: To determine overall safety profile, recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD)
Time frame: 28 days
Endpoint/Outcome Measures: Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-Limiting Toxicities (DLT) (in dose escalation part), AEs leading to treatment discontinuation; and clinically significant findings on clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examinations, using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
Phase 2A: To determine the clinical efficacy by Progression Free Survival (PFS) rate
Time frame: 12 months
Progression Free Survival (PFS) rate at 12 months from STC-1010 + IS regimen initiation, defined as the proportion of participants alive and without progression (i.e., participants with complete response [CR], partial response [PR] or stable disease [SD]) at 12 months according to RECIST 1.1
9 secondary outcomes
Phase 1: To determine the preliminary clinical efficacy
Time frame: 6 months
Phase 1: To describe the effects on cell-mediated immunity
Time frame: Up to 72 hours post injection
Phase 2A: To determine the overall safety and tolerability profile
Time frame: 6, 12 and 24 months
Phase 2A: To determine the clinical efficacy by Clinical Benefit Rate (CBR)
Time frame: 12 and 24 months
Phase 2A: To determine the clinical efficacy by Objective Response Rate (ORR)
Time frame: 6, 12 and 24 months
Phase 2A: To determine the clinical efficacy by Duration of Response (DOR)
Time frame: 6,12 and 24 months
Phase 2A: To determine the clinical efficacy by Progression Free Survival (PFS)
Time frame: 6,12 and 24 months
Phase 2A: To determine the clinical efficacy by Overall Survival (OS)
Time frame: 12 and 24 months
Phase 2A: To determine the clinical efficacy by metastases resection rate
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah KERBOUCHE contact
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STC-1010 + IS regimen + SOC therapy in people with Unresectable Metastatic Colorectal Cancer and Unresectable Locally Advanced Colorectal Cancer, run by Brenus Pharma at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne TORTORELLI, Pharm.D, Ph.D (+33 788 72 50 04, ctortorelli@brenus-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: To determine overall safety profile, recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.