41 Participants NeededMy employer runs this trial

SAR445877 + FOLFOX6 + Bevacizumab for Colorectal Cancer

AN
Overseen ByAung Naing, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new drug, SAR445877 (experimental treatment), combined with FOLFOX6 (a chemotherapy regimen) and bevacizumab (an anti-cancer drug), can be safely administered to individuals with advanced colorectal cancer that is microsatellite stable (MSS) and has spread. Researchers are identifying the right dose and assessing whether this combination can effectively treat the cancer. The trial seeks participants with advanced-stage colorectal cancer that is untreated and confirmed as MSS. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that SAR445877 is generally safe when used alone in patients with advanced solid tumors, meaning most people did not experience severe side effects. The treatment also showed promise in fighting tumors. However, ongoing tests aim to ensure its safety and effectiveness.

FOLFOX6 and bevacizumab are already approved for treating colorectal cancer and are generally considered safe for this use.

Currently, researchers are studying the combination of SAR445877 with these treatments. The trial is in an early phase, focusing on ensuring the combination's safety for humans. This research will help scientists understand how well these treatments work together and ensure they do not cause serious harm.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about SAR445877 for colorectal cancer because it introduces a new active ingredient that may enhance the effectiveness of existing treatments like FOLFOX6 and Bevacizumab. Unlike standard chemotherapy, which broadly targets rapidly dividing cells, SAR445877 is designed to more precisely target cancer cells, potentially leading to better outcomes and fewer side effects. This precision approach could transform the way colorectal cancer is treated by increasing the efficacy of existing regimens and reducing the burden on patients.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Studies have shown that SAR445877 shows promise as a cancer treatment. In earlier research, it helped shrink tumors in patients with advanced colorectal cancer, which starts in the colon or rectum. One study found that two patients had partial responses, with their tumors shrinking for several months. SAR445877 also performed well in lab tests on cancer resistant to other treatments. This trial will evaluate SAR445877 in combination with FOLFOX6 and bevacizumab. Although still in early stages, these signs suggest SAR445877 could be effective when used with these other drugs.12346

Who Is on the Research Team?

AN

Aung Naing, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with metastatic colorectal cancer that is microsatellite stable (MSS) and has not been treated before for advanced disease. Participants must be in good physical condition, have adequate blood counts, and be able to follow study procedures.

Inclusion Criteria

6. Measurable disease per the RECIST v1.1.
* Absolute neutrophil count ≥1500/mL
I meet the study's requirements to participate.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

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.

12 weeks

Dose Expansion

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.

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • FOLFOX6
  • SAR445877

Trial Overview

The study tests a new drug called SAR445877 combined with standard chemotherapy (FOLFOX6) and bevacizumab as the first treatment for people with MSS metastatic colorectal cancer. The main goal is to see if this combination can be given safely.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Dose EXP (Part 2)Experimental Treatment2 Interventions
Group II: Dose ESC (Part 1)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Sanofi

Industry Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

Initial safety and efficacy results from a first-in-human, ...

Conclusions: SAR445877 monotherapy demonstrated a tolerable safety profile and promising antitumor activity in pts with advanced solid tumors ...

SAR-445877 by Sanofi for Colorectal Cancer: Likelihood of ...

According to GlobalData, Phase II drugs for Colorectal Cancer have a 25% phase transition success rate (PTSR) indication benchmark for ...

First-in-human phase I study to evaluate safety, tolerability, ...

Two patients with microsatellite-stable colorectal cancer had partial response (duration of response 9.5 and 3 months). •. The rate of ADA development was 93.9% ...

Preclinical characterization of SAR445877, an anti-PD-1 ...

SAR445877 exhibited potent anti-tumor efficacy in PD-1 resistant preclinical model with good tolerability. These results support further ...

A First-in-human, Dose Escalation and Dose Expansion ...

This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in ...

Trial | NCT05584670

This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with ...