Date: 2014-06-24
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Sanofi (France)
Product: SAR408701
Action
mechanism: antibody drug conjugate. SAR408701 is an anti-CEACAM5 antibody drug conjugate. Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) also known as CD66e is a cell surface glycoprotein that represents the founding member of the carcinoembryonic antigen (CEA) family of proteins. This protein is used as a clinical biomarker for gastrointestinal cancers and may promote tumor development through its role as a cell adhesion molecule. Additionally, the encoded protein may regulate differentiation, apoptosis, and cell polarity.
Disease: solid tumors
Therapeutic area: Cancer - Oncology
Country: Canada, France, Republic of Korea, Spain
Trial
details: This first-in-human study will evaluate 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 to patients with advanced solid tumors (Escalation Phase). To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase). 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.(NCT02187848)
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