A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
Start Date
11/29/2022
Completion Date
6/28/2028
Summary
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.
Detailed Description
The duration of the study for a participant will include: * Screening Period: up to 28 days * Treatment Period: enrolled and exposed participants will receive continuous treatment until progressive disease (PD), or an occurrence of an unacceptable AE, a withdrawal of consent, or until other permanent discontinuation criteria described in the protocol are met. The End of Treatment (EOT) visit will occur 30 days ±7 days from the last IMP administration or prior to the initiation of further therapy, whichever occurs first. The follow-up period will occur until disease progression, the start of new anticancer therapy, death, or withdrawal of participant's consent, whichever comes first.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
SAR445877
Cetuximab
ADG126
Bevacizumab
Nivolumab
Ipilimumab
Conditions
Locations
Christiana Care Health System - Newark- Site Number : 8400011
Newark, Delaware 19718
United States
University of Iowa- Site Number : 8400014
Iowa City, Iowa 52242
United States
The University of Kansas Cancer Center - Westwood- Site Number : 8400008
Westwood, Kansas 66205
United States
Karmanos Cancer Institute - Detroit- Site Number : 8400006
Detroit, Michigan 48201
United States
John Theurer Cancer Center- Site Number : 8400001
Hackensack, New Jersey 07601
United States
NYU Langone Medical Center- Site Number : 8400013
New York, New York 10016
United States
Rhode Island Hospital - Providence - Eddy Street- Site Number : 8400004
Providence, Rhode Island 02905
United States
The University of Texas MD Anderson Cancer Center- Site Number : 8400005
Houston, Texas 77030
United States
Fred Hutchinson Cancer Center- Site Number : 8400010
Seattle, Washington 98109
United States
Servicios Médicos URUMED SpA_Investigational Site Number : 1520002
Rancagua, General Bernardo O'Higgins 2852424
Chile
BIOCINETIC Ltda_Investigational Site Number : 1520008
Santiago, Reg Metropolitana de Santiago 8331143
Chile
Centro de Investigacion Clinica Bradford Hill_Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago 8420383
Chile
Fundacion Arturo Lopez Perez (FALP) - Providencia - Jose Manuel Infante 805_Investigational Site Number : 1520007
Providencia, 7500000
Chile
Hadassah Medical Center - PPDS_Investigational Site Number : 3760005
Jerusalem, Jerusalem 9112001
Israel
Sheba Medical Center - PPDS_Investigational Site Number : 3760003
Ramat Gan, 5262100
Israel
Tel Aviv Sourasky Medical Center Ichilov - PPDS_Investigational Site Number : 3760001
Tel Aviv, 6423906
Israel
Shamir Medical Center_Investigational Site Number : 3760004
Tzrifin, 7033001
Israel
Investigational Site Number : 3920001
Kashiwa, Chiba 277-8577
Japan
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis_Investigational Site Number : 5280001
Amsterdam, North Holland 1066 CX
Netherlands
Erasmus MC_Investigational Site Number : 5280003
Rotterdam, South Holland 3015 CE
Netherlands
Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON_Investigational Site Number : 7240007
Barcelona, Barcelona [Barcelona] 08035
Spain
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC_Investigational Site Number : 7240005
Madrid, 28050
Spain