Actively Recruiting
Phase 1 Study Of SAR445877 With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-06-01
41
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and appropriate dosing of SAR445877 combined with FOLFOX6 and bevacizumab as a first treatment for patients with advanced microsatellite stable metastatic colorectal cancer (CRC). This Phase 1 study aims to find the highest tolerated dose and recommended dose of this combination, while also monitoring its effect on tumor response in participants who have not previously been treated for metastatic disease. The study features two parts: a dose escalation phase where three dose levels of SAR445877 are tested using a specific design to find the maximum tolerated dose, followed by a dose expansion phase to further assess this dose. All drugs, including SAR445877, FOLFOX6, and bevacizumab, are given intravenously. Participants receive these treatments as part of the study protocol to evaluate safety and potential antitumor effects. During the study, participants will undergo regular visits for treatment administration and monitoring. Researchers will assess safety through tracking adverse events over about one year. Participants must meet specific health requirements, including measurable disease and good organ function, and will be monitored with lab tests and clinical evaluations. The study continues until completion, allowing researchers to collect data on tolerability and tumor response.
CONDITIONS
Brief Title
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent before study procedures
- Willing to comply with scheduled visits, treatments, tests, and study procedures
- Age 18 years or older
- Histologically confirmed metastatic colorectal cancer with no prior metastatic treatment; if received adjuvant FOLFOX, must be 6 months from treatment
- Colorectal cancer confirmed as microsatellite stable
- Measurable disease based on RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Adequate organ and marrow function within 28 days before treatment start, including specified blood counts and liver/kidney function
- Life expectancy of at least 3 months
- Women of childbearing potential must agree to use effective contraception before and during treatment and for 9 months after
- Male participants must agree to use effective contraception during treatment and for 6 months after last dose
- Women of childbearing potential must have a negative pregnancy test within 3 days before first treatment
You will not qualify if you...
- Pregnant or breastfeeding
- Significant autoimmune diseases requiring systemic immunosuppressive treatment within 2 years, except certain mild conditions
- Receiving other investigational agents
- Live-virus vaccination within 28 days before study treatment
- Systemic corticosteroids or immunosuppressive medication within 1 week prior to treatment start, except physiologic replacement or short courses
- Known HIV infection with low CD4 count
- Acute or chronic hepatitis B or C infection
- Previous solid organ or allogeneic stem cell transplant
- Active brain or leptomeningeal metastases
- Active infection requiring intravenous antibiotics or uncontrolled illness needing hospitalization
- History of interstitial lung disease or severe obstructive pulmonary disease
- Serious cardiovascular or cerebrovascular disease
- Left ventricular ejection fraction below 50%
- Serious non-healing wounds, ulcers, or bone fractures
- Recent abdominal fistula, gastrointestinal perforation, or abscess within 6 months
- Bleeding disorders or coagulopathy
- Uncontrolled high blood pressure
- Significant proteinuria above specified levels
- Severe allergic reactions to monoclonal antibodies or recent anaphylaxis
- Additional progressing malignancies requiring active treatment
- Psychiatric or substance abuse disorders interfering with study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive SAR445877 in combination with FOLFOX6 and bevacizumab as first-line treatment for metastatic colorectal cancer.
Regular visits for IV treatments and assessments during treatment
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Aung Naing, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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