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A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors
Primary Objectives: * To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W). * To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle). * To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1. Secondary Objectives: * To characterize the overall safety profile of SAR408701. * To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives. * To identify the recommended phase 2 dose (RP2D) of SAR408701. * To assess the potential immunogenicity of SAR408701.
The study duration for an individual patient will start from the signature of the informed consent, will include a period to assess eligibility (screening period) of up to approximately 4 weeks (28 days), a treatment period and an end-of-treatment visit around 30 days following the last administration of study drug, and at least one follow-up visit after the end-of-treatment visit. Additional follow-up visits may be required until resolution or stabilization of adverse events (at least 30 days). Treatment may continue until precluded by toxicity, progression, or upon patient's request. If the patient stops study treatment for reason other than disease progression, follow-up visit will be performed every 3 months until disease progression or initiation of another anti-tumor treatment or death, whichever comes first.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Yale University School of Medicine Site Number : 840002
New Haven, Connecticut, United States
Dana Farber Cancer Institute- Site Number : 840005
Boston, Massachusetts, United States
Investigational Site Number : 124001
Toronto, Ontario, Canada
Investigational Site Number : 250003
Bordeaux, France
Investigational Site Number : 250006
Dijon, France
Investigational Site Number : 250004
Marseille, France
Investigational Site Number : 250007
Rennes, France
Investigational Site Number : 250005
Saint-Mandé, France
Investigational Site Number : 250002
Toulouse, France
Investigational Site Number : 250001
Villejuif, France
Start Date
July 23, 2014
Primary Completion Date
November 10, 2020
Completion Date
November 19, 2024
Last Updated
February 10, 2025
254
ACTUAL participants
SAR408701
DRUG
Lead Sponsor
Sanofi
NCT07209111
NCT06310330
NCT05247268
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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