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

Inclusion criteria

• 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 criteria

• 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.