RECRUITING

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

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Conditions

Unresectable Metastatic Colorectal CancerUnresectable Locally Advanced Colorectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Open Label, Multicenter, Dose-escalation and Cohort-expansion Phase I/IIA Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer (CRC) - BreAK CRC Trial (BreAK for Brenus Anti-cancer)

Quick Facts

Study Start:2025-06-17
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06934538

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female aged 18-75 years
  2. 2. Histologically confirmed diagnosis of unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) (R0) adenocarcinoma of the colon or rectum
  3. 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. 4. Determination of KRAS and BRAF mutation status
  5. 5. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  6. 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. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. Participants \>70 years must have a PS= 0.
  8. 8. Life expectancy \> 3 months as assessed by the investigator
  9. 9. Effective contraceptive measures implemented
  1. 1. Patients with symptomatic ascites or pleural effusion
  2. 2. Dihydropyrimidine dehydrogenase (DPD) deficiency
  3. 3. Resectable tumor with curative intent or patient considered for a curative strategy by intensifying chemotherapy to induce resectability
  4. 4. Prior chemotherapy for metastatic disease
  5. 5. Prior immunotherapy for advanced/metastatic disease (except for Arm 2A-2)
  6. 6. Prior therapy with an investigational agent
  7. 7. BRAF mutation
  8. 8. Active auto-immune diseases such as rheumatoid arthritis, lupus, Crohn's disease, ulcerative colitis
  9. 9. Medical conditions requiring immunosuppressive therapy
  10. 10. Major surgery \<4 weeks prior to first administration of STC-1010
  11. 11. Radiotherapy \< 4 weeks prior to first administration of STC-1010 or \< 2 weeks in case of palliative radiotherapy
  12. 12. Prior stem cell or solid organ transplantation
  13. 13. Dementia or altered mental status or subject of a legal protection measure that would prohibit informed consent
  14. 14. Active drug or alcohol abuse as assessed by the Investigator
  15. 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.

Contacts and Locations

Study Contact

Corinne TORTORELLI, Pharm.D, Ph.D
CONTACT
+33 788 72 50 04
ctortorelli@brenus-pharma.com
Rebecca TANZI
CONTACT
rtanzi@brenus-pharma.com

Study Locations (Sites)

Johns Hopkins
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Brenus Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-17
Study Completion Date2029-06

Study Record Updates

Study Start Date2025-06-17
Study Completion Date2029-06

Terms related to this study

Additional Relevant MeSH Terms

  • Unresectable Metastatic Colorectal Cancer
  • Unresectable Locally Advanced Colorectal Cancer