First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests STC-1010, an immune-based treatment, in people for the first time. It checks its safety, dose, and how well it works when given with immune-stimulating drugs and standard cancer treatment. It is for adults ages 18–75 with colon or rectal cancer that has spread nearby or to distant parts of the body and cannot be removed by surgery.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18–75, with lab-confirmed adenocarcinoma, a type of colon or rectal cancer, at stage IIIC (T4b) or stage IV that cannot be removed by surgery.
- If you had fluoropyrimidine alone or oxaliplatin-based chemotherapy after surgery, more than 6 months must have passed before the cancer first returned.
- Have test results for changes in the KRAS and BRAF genes.
- Have cancer that can be measured on scans.
- Agree to have small tissue samples taken before and during treatment, if the study doctors judge this safe and possible.
- Be fully active or have only limits on strenuous activity. If older than 70, you must be fully active.
- The study doctor expects you to live more than 3 months.
- Use effective birth control.
Who can't join
- Fluid buildup in the belly or around the lungs that causes symptoms; DPD deficiency, which means too little of an enzyme that breaks down certain cancer drugs; or a BRAF gene change.
- Cancer that could be cured by surgery, or a plan to use stronger chemotherapy to make surgery possible for a cure.
- Past chemotherapy for cancer that spread to distant sites; past immune treatment for advanced cancer, except in study group 2A-2; or past treatment with an experimental drug.
- An active disease in which the immune system attacks the body, such as rheumatoid arthritis, lupus, Crohn’s disease, or ulcerative colitis; or a condition needing drugs that weaken the immune system.
- Major surgery or radiation within 4 weeks before the first STC-1010 dose. For radiation to ease symptoms, the limit is 2 weeks.
- A past stem cell or organ transplant.
- Dementia, changes in mental awareness, or a legal protection order that prevents informed consent; or active drug or alcohol abuse, as judged by the study doctor.
- Loss of freedom under a court or government order, or psychiatric care with admission to a health or social care facility for reasons other than research.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
MD
- Johns Hopkins · Baltimore, MD 21287Eric Christenson, MD · Study contact · 410-955-8964 · echris14@jhmi.eduMore trials in Baltimore