Status:
RECRUITING
First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
Lead Sponsor:
Brenus Pharma
Conditions:
Unresectable Metastatic Colorectal Cancer
Unresectable Locally Advanced Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 cycl...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06934538
Start Date
June 17 2025
End Date
June 1 2029
Last Update
December 22 2025
Active Locations (9)
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1
Johns Hopkins
Baltimore, Maryland, United States, 21287
2
Institut Jules Bordet
Brussels, Belgium
3
Institut Bergonié
Bordeaux, France
4
Centre Georges François Leclerc (CGFL)
Dijon, France