First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer

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.