Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal 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 and older
- 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 whether SAR445877 can be safely given with FOLFOX6 chemotherapy and bevacizumab. It is for adults with colorectal cancer (cancer of the colon or rectum) that has spread and has a test result called microsatellite stable (MSS). Participants must not have had treatment for cancer that has spread.
To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, agree to join, and be able to follow the study visits, treatments, and tests.
- Have colorectal cancer confirmed by a tissue test, with cancer that has spread and an MSS test result.
- Have had no treatment for cancer that has spread. If you had FOLFOX after surgery, at least 6 months must have passed since that treatment.
- Have cancer that can be measured on scans.
- Be fully active or able to do light work despite some limits on hard physical activity. Be expected to live at least 3 months.
- Have blood, liver, kidney, and blood-clotting test results that meet study limits within 28 days before treatment. If taking blood thinners, your dose plan must be stable.
- If you can become pregnant, use approved birth control before treatment, during treatment, and for 9 months after it ends. Have a negative blood pregnancy test within 3 days before treatment starts.
- Male participants must use approved birth control during treatment and for 6 months after the last dose.
Who can't join
- Be pregnant or breastfeeding; be taking another study drug; or have received a live-virus vaccine within 28 days before treatment.
- Have a serious autoimmune disease (the immune system attacks the body) needing immune-suppressing drugs now or in the past 2 years, or need certain steroids or immune-suppressing drugs within 1 week before treatment. Some conditions and steroid uses are allowed.
- Have HIV or AIDS unless your latest CD4 immune-cell count is above 500; have hepatitis B or C; or have had an organ transplant or a stem cell transplant from a donor.
- Have active cancer spread to the brain or its lining; an infection needing antibiotics through a vein; or another uncontrolled illness needing a hospital stay.
- Have certain serious lung, heart, or brain blood-vessel diseases; a heart pumping level below 50%; blood pressure above 150/100; bleeding or blood-clotting problems; or too much protein in urine, unless follow-up testing meets study limits.
- Have a serious wound, sore, or broken bone that is not healing. Also excluded: an abnormal passage in the belly, a hole in the stomach or bowel, or a pocket of infection in the belly within the past 6 months.
- Have a known severe allergic reaction to monoclonal antibodies (a type of medicine), or any history of anaphylaxis (a life-threatening allergic reaction).
- Have another cancer that is growing or needs treatment, except certain skin or early cervical cancers; or have a mental health or substance use disorder that would prevent following study requirements.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Eligibility Criteria 1. Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures. 2. Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures. 3. Age ≥18 years. 4. 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 the time of enrollment. 5. CRC documented as MSS by immunohistochemistry, next-generation sequencing, or polymerase chain reaction assay at any time prior to screening. 6. Measurable disease per the RECIST v1.1. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. 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 anticoagulant regimen. 9. Life expectancy ≥ 3 months. 10. 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 birth control; abstinence) prior to study entry, for the duration of the study treatment period, and for 9 months after completion of study treatment. (Refer to Pregnancy Assessment Policy MD Anderson Cancer Center \[MDACC\] Institutional Policy # CLN1114). WOCBP includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following: * 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, patient/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the duration of the study treatment period and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 11. 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 12. WOCBP must have a negative serum pregnancy test within 3 days prior to first administration of study treatment. Exclusion Criteria 1. Pregnant or breastfeeding. 2. 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 following conditions are eligible: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment. 3. Participants who are receiving any other investigational agents. 4. 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 days prior to Cycle 1 Day 1 through Cycle 2 Day 3). 5. 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 study treatment. Physiologic replacement doses are allowed even if they are \>10 mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided they are not for the treatment of an autoimmune disorder. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are eligible to be enrolled in the study. 6. Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome, unless most recent CD4 count exceeds 500 cells/mm3. 7. Acute or chronic hepatitis B virus or hepatitis C virus infection. 8. Previous solid organ or allogeneic hematopoietic stem cell transplant. 9. Active brain or leptomeningeal metastases. 10. Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization. 11. History of interstitial lung disease or severe obstructive pulmonary disease. 12. Clinically significant cardiovascular/cerebrovascular disease. 13. Left ventricular ejection fraction \<50% as measured by echocardiogram or multigated acquisition scan. 14. Serious, non-healing wound, ulcer, or bone fracture. 15. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to first administration of study treatment. 16. Evidence of bleeding or coagulopathy. 17. Uncontrolled hypertension (\>150/100 mmHg). 18. 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. 19. Known severe hypersensitivity reactions to monoclonal antibodies, any history of or recent (within 6 months) anaphylaxis. 20. 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 in situ cervical cancer. 21. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study. \-
Study sites (1)
TX
- MD Anderson Cancer Center · Houston, TX 77030Aung Naing, MD · Study contact · 713-563-3885 · anaing@mdanderson.orgAung Naing, MD · Principal investigatorMore trials in Houston