Date: 2015-10-08
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Sanofi
Product: SAR428926
Action
mechanism: antibody drug conjugate (ADC). SAR428926 is a LAMP1-targeting ADC initially developed by Immunogen.
Disease: advanced solid tumors
Therapeutic area: Cancer - Oncology
Country: Denmark, France, Spain
Trial
details: This first-in-human phase 1 dose escalation study of SAR428926 in patients with advanced solid tumors aims to determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors. It will also evaluate the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926. Secondary objectives : To determine the overall safety profile of SAR428926 as a single agent. - To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites. - To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. - To evaluate the immunogenicity of SAR428926. - To assess the tumor response and duration of tumor response in all treated patients. (NCT02575781)
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