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

Launched by BRENUS PHARMA · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called STC-1010 for patients with advanced colorectal cancer that cannot be surgically removed. The study aims to see how safe the treatment is and how well it works when combined with standard chemotherapy. It is being conducted in two parts: the first part will determine the best and safest dose of STC-1010, while the second part will involve more patients to further assess its effectiveness.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of locally advanced or metastatic colorectal cancer. They should not have received certain previous treatments and must meet specific health guidelines. Participants will receive the new treatment along with standard care and will be monitored closely by the study team. It’s important to note that the trial is not yet recruiting participants, so interested individuals will need to wait for it to start.

Gender

ALL

Eligibility criteria

• 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.