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New treatment option for Phase 1
Official title Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07500298
What this study is testing
What is SAR445877?
SAR445877 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for phase 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility Criteria
- Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
- Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures.
- Age ≥18 years.
- Participants with histologically documented CRC with metastatic disease who have not received prior treatment in the metastatic setting. Participants...
You likely can't join if
- Pregnant or breastfeeding.
- Ongoing or recent (within 2 years) evidence of significant autoimmune disease that requires/required treatment with systemic immunosuppressive...
- Participants who are receiving any other investigational agents.
- Receipt of a live-virus vaccination within 28 days prior to study treatment initiation. Non-live COVID vaccines will be allowed on study, but it is...
- Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other...
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome, unless most recent CD4 count exceeds 500...
See the full eligibility criteria
Who can join
- Eligibility Criteria
- Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
- Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures.
- Age ≥18 years.
- Participants with histologically documented CRC with metastatic disease who have not received prior treatment in the metastatic setting. Participants who have received adjuvant FOLFOX must be 6 months from treatment at...
- CRC documented as MSS by immunohistochemistry, next-generation sequencing, or polymerase chain reaction assay at any time prior to screening.
- Measurable disease per the RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and marrow function as defined below within 28 days of study treatment initiation:
- Hemoglobin \>9.0 g/dL
- Absolute neutrophil count ≥1500/mL
- Platelets ≥100,000/mL
- Total bilirubin ≤1.5 × institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤2.5 × institutional ULN. Transaminases up to 3 × ULN in the presence of liver metastases.
- Estimated glomerular filtration rate ≥50 mL/min/1.73 m² (Modification of Diet in Renal Disease Formula)
- For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For participants receiving therapeutic anticoagulation: stable...
- Life expectancy ≥ 3 months.
- The effects of SAR445877 and FOLFOX/bevacizumab on the developing human fetus are unknown. For this reason, women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of...
- Postmenopausal (no menses in ≥12 consecutive months)
- History of hysterectomy or bilateral salpingo-oophorectomy
- Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy)
- History of bilateral tubal ligation or another surgical sterilization procedure
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation or hysterectomy...
- Male participants must agree to use adequate contraception throughout the duration of the study treatment period and for 6 months after the last dose of study treatment
- WOCBP must have a negative serum pregnancy test within 3 days prior to first administration of study treatment.
What rules you out
- Pregnant or breastfeeding.
- Ongoing or recent (within 2 years) evidence of significant autoimmune disease that requires/required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs. Participants with the...
- Participants who are receiving any other investigational agents.
- Receipt of a live-virus vaccination within 28 days prior to study treatment initiation. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3...
- Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 1 week prior to the first administration of...
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome, unless most recent CD4 count exceeds 500 cells/mm3.
- Acute or chronic hepatitis B virus or hepatitis C virus infection.
- Previous solid organ or allogeneic hematopoietic stem cell transplant.
- Active brain or leptomeningeal metastases.
- Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.
- History of interstitial lung disease or severe obstructive pulmonary disease.
- Clinically significant cardiovascular/cerebrovascular disease.
- Left ventricular ejection fraction \<50% as measured by echocardiogram or multigated acquisition scan.
- Serious, non-healing wound, ulcer, or bone fracture.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to first administration of study treatment.
- Evidence of bleeding or coagulopathy.
- Uncontrolled hypertension (\>150/100 mmHg).
- Urine dipstick of proteinuria \>2+. Participants with \>2+ proteinuria on dipstick analysis will undergo a 24-hour urine collection and must demonstrate \<1.0 g protein/24 hours to be eligible.
- Known severe hypersensitivity reactions to monoclonal antibodies, any history of or recent (within 6 months) anaphylaxis.
- Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or...
- Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study. \-
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.