Spots Global Cancer Trial Database for A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers

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Trial Identification

Brief Title: A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers

Official Title: A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of SAR245408 Administered in Combination With SAR256212 in Patients With Solid Tumor Cancers

Study ID: NCT01436565

Conditions

Solid Tumor Cancers

Interventions

MM-121 (SAR256212)

SAR245408

Study Description

Brief Summary: Primary Objective: * To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors. Secondary Objectives: * To characterize the global safety profile of SAR245408 in combination with SAR256212 * To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination * To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only) * To determine the immunogenicity of SAR256212 as administered with SAR245408

Detailed Description: There is a 28 day screening period followed by 28 day cycles (21 day cycle for the every three week dosing regimen, if used) . Patients will continue to receive SAR245408/SAR256212 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 60 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.