First use of STC-1010 immunotherapy with standard chemotherapy for unresectable locally advanced or metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label Phase I/IIa trial combining STC-1010 with an immunostimulant regimen (GM-CSF and low-dose cyclophosphamide) given alongside standard mFOLFOX6 chemotherapy with or without bevacizumab. Phase I uses dose escalation and a small expansion to define the maximum tolerated dose and recommended Phase II dose, enrolling about 21–33 participants in Europe, followed by a Phase IIa expansion to further evaluate safety and early efficacy. Participants must have unresectable locally advanced (stage IIIC, T4b) or metastatic (stage IV) colorectal adenocarcinoma with measurable disease and an ECOG performance status of 0–1, and will undergo baseline and on-treatment biopsies when feasible. The study is multicenter with response assessed by RECIST 1.1 and close safety monitoring throughout treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institut Jules Bordet
  Brussels, Belgium Recruiting
• Institut Bergonié
  Bordeaux, France Recruiting
• Centre Georges François Leclerc (CGFL)
  Dijon, France Recruiting
• Centre Léon Bérard (CLB)
  Lyon, France Recruiting
• Hospices Civils de Lyon (HCL)
  Lyon, France Recruiting
• Institut du Cancer de Montpellier (ICM)
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Corinne TORTORELLI, Pharm.D, Ph.D
• Email: ctortorelli@brenus-pharma.com
• Phone: +33 788 72 50 04

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bevacizumab Dose Tuning in First-Line Metastatic Colorectal Cancer Based on Blood Levels

  This trial tests whether doubling the bevacizumab dose in patients with low initial bevacizumab blood levels improves outcomes in first-line unresectable metastatic colorectal cancer.

  Recruiting at 2 sites Phase 3 University Hospital, Tours · Besançon and 3 other locations · NCT06642844

• Treatment for advanced colorectal cancer using CYAD-101 and pembrolizumab

  This study is testing a new treatment combining CYAD-101 with chemotherapy and pembrolizumab to see if it helps people with advanced colorectal cancer who haven't had success with other treatments.

  Recruiting at 2 sites Phase 1 Celyad Oncology SA · Jacksonville, Florida and 4 other locations · NCT04991948

• Combination of chemotherapy and immunotherapy for advanced colorectal cancer

  This study is testing if a new immune therapy combined with standard chemotherapy can help people with advanced colorectal cancer feel better and improve their treatment outcomes.

  Recruiting at 3 sites Phase 1 Celyad Oncology SA · Tampa, Florida and 3 other locations · NCT03692429

• Pumitamig plus chemotherapy versus bevacizumab plus chemotherapy for untreated metastatic colorectal cancer

  This trial tests whether adding the new drug pumitamig to standard chemotherapy works better than bevacizumab plus chemotherapy for people with previously untreated, unresectable, or metastatic colorectal cancer who do not have MSI‑H/dMMR or BRAF V600E mutations.

  Recruiting at 209 sites Phase 2/3 Bristol-Myers Squibb · Tucson, Arizona and 285 other locations · NCT07221357

• EMB-01 plus chemotherapy for unresectable or metastatic colorectal cancer

  This early-phase trial tests EMB-01 in combination with chemotherapy to see if it is safe and helps treat people with unresectable or metastatic colorectal cancer.

  Recruiting at 2 sites Phase 1 Shanghai EpimAb Biotherapeutics Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07649655

• Long-term follow-up after cadonilimab (AK104) treatment

  This follow-up collects long-term health and survival information from people with advanced gastric cancer who previously received cadonilimab (AK104) in earlier clinical trials.

  Recruiting Akeso · Beijing · NCT07547787

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.