New immunotherapy combo takes on advanced colorectal cancer
NCT ID NCT06934538
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a new immunotherapy called STC-1010 combined with standard chemotherapy and immune boosters in people with advanced colorectal cancer that cannot be removed by surgery. The study has two parts: first, finding the safest dose in about 21-33 participants, then testing how well it works in about 57-60 more. The goal is to see if the treatment can control the cancer and improve survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- STC-1010 (an immunotherapy) plus immunostimulants (cyclophosphamide and GM-CSF) and standard chemotherapy (mFOLFOX6 with or without bevacizumab)
- What this could lead to
- If successful, this could lead to a new treatment option that helps control advanced colorectal cancer and may extend the time without the disease worsening.
- What could go wrong
- This is an early phase I/IIA trial with a small number of participants, so the treatment may not prove effective or safe in larger studies. Side effects from the immunotherapy and chemotherapy are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
-
Jun 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female aged 18-75 years 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: 1. Patients with symptomatic ascites or pleural effusion 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Unresectable locally advanced colorectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
9 sites in 3 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Centre Georges François Leclerc (CGFL)
RECRUITINGDijon, France
-
Centre Hospitalier Universitaire de Poitiers (CHU)
NOT_YET_RECRUITINGPoitiers, France
-
Centre Léon Bérard (CLB)
NOT_YET_RECRUITINGLyon, France
-
Hospices Civils de Lyon (HCL)
RECRUITINGLyon, France
-
Institut Bergonié
RECRUITINGBordeaux, France
-
Institut Gustave Roussy (IGR)
RECRUITINGVillejuif, France
-
Institut Jules Bordet
NOT_YET_RECRUITINGBrussels, Belgium
-
Institut du Cancer de Montpellier (ICM)
RECRUITINGMontpellier, France
-
Johns Hopkins
NOT_YET_RECRUITINGBaltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Smart dosing: tailoring cancer drug levels could extend life for colorectal patients
- New antibody combo takes on tough colorectal cancer
- New chemo cocktail aims to slow advanced colon cancer
- Blood test may predict when colorectal cancer treatment fails
- New combo aims to shrink Hard-to-Treat colon tumors
- New drug JNJ-89402638 enters human trials for Tough-to-Treat GI cancers