Actively Recruiting
First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
Led by Brenus Pharma · Updated on 2025-12-22
90
Participants Needed
9
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18-75 years
- Histologically confirmed unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) adenocarcinoma of the colon or rectum
- Adjuvant fluoropyrimidine monotherapy or oxaliplatin-based chemotherapy allowed if more than 6 months have passed since end of adjuvant treatment and first relapse
- Determination of KRAS and BRAF mutation status
- Measurable disease according to RECIST 1.1 criteria
- Agree to biopsy at screening and during treatment if safe and feasible
- Eastern Cooperative Oncology Group performance status 0 or 1; participants over 70 must have status 0
- Life expectancy greater than 3 months
- Use of effective contraceptive measures
You will not qualify if you...
- Symptomatic ascites or pleural effusion
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- Resectable tumor planned for curative surgery or considered for curative chemotherapy
- Prior chemotherapy for metastatic disease
- Prior immunotherapy for advanced/metastatic disease (except for Arm 2A-2)
- Prior treatment with investigational agents
- Presence of BRAF mutation
- Active autoimmune diseases such as rheumatoid arthritis, lupus, Crohn's disease, or ulcerative colitis
- Medical conditions requiring immunosuppressive therapy
- Major surgery within 4 weeks before first dose of STC-1010
- Radiotherapy within 4 weeks before first dose of STC-1010 or within 2 weeks if palliative
- Prior stem cell or organ transplant
- Dementia, altered mental status, or legal protection preventing informed consent
- Active drug or alcohol abuse
- Participant deprived of liberty by legal or administrative decision, undergoing psychiatric care, or admitted for non-research purposes
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Trial Site Locations
Total: 9 locations
1
Johns Hopkins
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
2
Institut Jules Bordet
Brussels, Belgium
Not Yet Recruiting
3
Institut Bergonié
Bordeaux, France
Actively Recruiting
4
Centre Georges François Leclerc (CGFL)
Dijon, France
Actively Recruiting
5
Centre Léon Bérard (CLB)
Lyon, France
Not Yet Recruiting
6
Hospices Civils de Lyon (HCL)
Lyon, France
Actively Recruiting
7
Institut du Cancer de Montpellier (ICM)
Montpellier, France
Actively Recruiting
8
Centre Hospitalier Universitaire de Poitiers (CHU)
Poitiers, France
Not Yet Recruiting
9
Institut Gustave Roussy (IGR)
Villejuif, France
Actively Recruiting
Research Team
C
Corinne TORTORELLI, Pharm.D, Ph.D
CONTACT
R
Rebecca TANZI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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