Solid Tumor Cancers Clinical Trial
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
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
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. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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