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Study identifier: NCT05584670 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors

Condition: Solid Tumor  ·  Sponsor: Sanofi

PhasePhase 1/Phase 2
Planned participants542
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors. The study will include 2 parts: A dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable. A multicohort dose expansion/dose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab or with next generation aCTLA4 (ADG126) or with bevacizumab. 2 recommended doses for expansion/optimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable. Approximately 542 participants will be exposed to the study intervention: * approximately 123 participants in part 1, * up to 410 participants in expansion/dose optimization part (part 2) * and up to 9 participants in Japan cohort F.

This description comes directly from the study's public registry record.

Talk to the study team

Trial Transparency email recommended (Toll free for US & Canada)  ·  800-633-1610  ·  contact-us@sanofi.com

Always discuss trial participation with your own doctor first.

Locations (22)

Christiana Care Health System - Newark- Site Number : 8400011Newark, Delaware, United StatesRecruiting
University of Iowa- Site Number : 8400014Iowa City, Iowa, United StatesRecruiting
The University of Kansas Cancer Center - Westwood- Site Number : 8400008Westwood, Kansas, United StatesRecruiting
Karmanos Cancer Institute - Detroit- Site Number : 8400006Detroit, Michigan, United StatesRecruiting
John Theurer Cancer Center- Site Number : 8400001Hackensack, New Jersey, United StatesRecruiting
NYU Langone Medical Center- Site Number : 8400013New York, New York, United StatesRecruiting
Rhode Island Hospital - Providence - Eddy Street- Site Number : 8400004Providence, Rhode Island, United StatesRecruiting
The University of Texas MD Anderson Cancer Center- Site Number : 8400005Houston, Texas, United StatesRecruiting
Fred Hutchinson Cancer Center- Site Number : 8400010Seattle, Washington, United StatesRecruiting
Servicios Médicos URUMED SpA_Investigational Site Number : 1520002Rancagua, General Bernardo O'Higgins, ChileRecruiting
BIOCINETIC Ltda_Investigational Site Number : 1520008Santiago, Reg Metropolitana de Santiago, ChileRecruiting
Centro de Investigacion Clinica Bradford Hill_Investigational Site Number : 1520004Santiago, Reg Metropolitana de Santiago, ChileRecruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05584670