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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Pharmaceutical form:solution Route of administration: Intravenous
Pharmaceutical form:tablet Route of administration: oral
Investigational Site Number 840001
Boston, Massachusetts, United States
Investigational Site Number 840101
Brookline, Massachusetts, United States
Investigational Site Number 840002
Nashville, Tennessee, United States
Maximum tolerated dose
Time frame: 2 months to 12 months
Peak and trough levels of SAR256212 and SAR245408
Time frame: 1 month to 6 months
Pharmacodynamic change in ErbB3 protein and mRNA levels as well as components of the PI3K pathway will be measured
Time frame: 1 month to 6 months
Number of participants with adverse events
Time frame: 1 month to 2 years
overall response rate
Time frame: 2 months to 2 years
Number of patients who develop anti-MM-121 antibodies
Time frame: 1 month to 6 months
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