Phase 1Phase 1NCT07500298
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
A Phase 1 study testing SAR445877, FOLFOX6 and Bevacizumab in people with Phase 1 and SAR445877, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SAR445877, FOLFOX6 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2026to 27 Dec 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 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.
- 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 days prior to Cycle 1 Day 1 through Cycle 2 Day 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 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.
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome, unless most recent CD4 count exceeds 500 cells/mm3.
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- 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 in situ cervical cancer.
- Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Aung Naing, MD, 713-563-3885, anaing@mdanderson.org
Aung Naing, MD
About this study
To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.
Read the detailed description
Primary Objective •To determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of SAR445877 + FOLFOX6 and bevacizumab in patients with MSS metastatic CRC.
Secondary Objective
•To evaluate the antitumor efficacy of SAR445877 + FOLFOX6 and bevacizumab in participants with MSS metastatic CRC.
- Conditions
- Phase 1, SAR445877, FOlfox6, Bevacizimab, First Line Treatment, Metastatic Colorectal Cancer (CRC)
- Being tested
- SAR445877, FOLFOX6, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR445877Drug
Given by IV
FOLFOX6Drug
Given by IV
BevacizumabDrug
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Dose ESC (Part 1) | Experimental | In the dose escalation part of the study, three dose levels of SAR445877 will be evaluated using the Bayesian optimal interval (BOIN) design to determine the MTD. Receives: Drug: SAR445877; Drug: FOLFOX6; Drug: Bevacizumab |
| Dose EXP (Part 2) | Experimental | The dose expansion part of the study will further evaluate the MTD, as determined in the dose escalation, and will be conducted using the Bayesian optimal Phase 2 (BOP2) design. Receives: Drug: SAR445877; Drug: FOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start20 May 2026
- Primary completion27 Dec 2030 (estimated)
- Study completion27 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Aung Naing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500298
- Sponsor's protocol ID
- 2025-1447
- Other IDs
- NCI-2026-02086
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2025-1447
- Conditions
- Phase 1, SAR445877, FOlfox6, Bevacizimab, First Line Treatment, Metastatic Colorectal Cancer (CRC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 20 May 2026 (actual)
- Primary completion
- 27 Dec 2030 (estimated)
- Study completion
- 27 Dec 2032 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.
Detailed description
Primary Objective •To determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of SAR445877 + FOLFOX6 and bevacizumab in patients with MSS metastatic CRC.
Secondary Objective
•To evaluate the antitumor efficacy of SAR445877 + FOLFOX6 and bevacizumab in participants with MSS metastatic CRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose ESC (Part 1) | Experimental | Drug: SAR445877, Drug: FOLFOX6, Drug: BevacizumabIn the dose escalation part of the study, three dose levels of SAR445877 will be evaluated using the Bayesian optimal interval (BOIN) design to determine the MTD. |
| Dose EXP (Part 2) | Experimental | Drug: SAR445877, Drug: FOLFOX6The dose expansion part of the study will further evaluate the MTD, as determined in the dose escalation, and will be conducted using the Bayesian optimal Phase 2 (BOP2) design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- 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 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.
- 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 days prior to Cycle 1 Day 1 through Cycle 2 Day 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR445877Given by IV | Drug | Dose ESC (Part 1), Dose EXP (Part 2) |
| FOLFOX6Given by IV | Drug | Dose ESC (Part 1), Dose EXP (Part 2) |
| BevacizumabGiven by IV | Drug | Dose ESC (Part 1) |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aung Naing, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR445877, FOLFOX6 and Bevacizumab in people with Phase 1 and SAR445877, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aung Naing, MD (713-563-3885, anaing@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.