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?

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

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?

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

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