Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer

NCT07500298 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2025-1447NCI-2026-02086
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.

Conditions

Phase 1; SAR445877; FOlfox6; Bevacizimab; First Line Treatment; Metastatic Colorectal Cancer (CRC); Microsatellite Stable

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year.

Study Arms (2)

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.

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.

Drug: SAR445877; Drug: FOLFOX6

Interventions

SAR445877 DRUG

Given by IV

Dose ESC (Part 1); Dose EXP (Part 2)

FOLFOX6 DRUG

Given by IV

Dose ESC (Part 1); Dose EXP (Part 2)

Bevacizumab DRUG

Given by IV

Dose ESC (Part 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Sanofi: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocol; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Aung Naing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aung Naing, MD

CONTACT

713-563-3885; anaing@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start (Estimated): September 3, 2026
• Primary Completion (Estimated): December 27, 2030
• Study Completion (Estimated): December 27, 2032
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)