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New immunotherapy combo takes on advanced colorectal cancer

NCT ID NCT06934538

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    9 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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)

    RECRUITING

    Dijon, France

  • Centre Hospitalier Universitaire de Poitiers (CHU)

    NOT_YET_RECRUITING

    Poitiers, France

  • Centre Léon Bérard (CLB)

    NOT_YET_RECRUITING

    Lyon, France

  • Hospices Civils de Lyon (HCL)

    RECRUITING

    Lyon, France

  • Institut Bergonié

    RECRUITING

    Bordeaux, France

  • Institut Gustave Roussy (IGR)

    RECRUITING

    Villejuif, France

  • Institut Jules Bordet

    NOT_YET_RECRUITING

    Brussels, Belgium

  • Institut du Cancer de Montpellier (ICM)

    RECRUITING

    Montpellier, France

  • Johns Hopkins

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

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