Primary Objective: \- To determine the maximum tolerated dose(s) (MTD) and the recommended Phase 2 dose(s) (RP2D) of SAR245408 and MSC1936369B when combined in adult subjects with locally advanced or metastatic solid tumors. Secondary Objective: * To characterize the safety and tolerability of SAR245408 and MSC1936369B combination therapy administered orally to adult patients with locally advanced or metastatic solid tumors * To evaluate the pharmacokinetic (PK) profile of SAR245408 and MSC1936369B when used in combination * To evaluate the pharmacodynamic (PD) effect of the SAR245408/MSC1936369B combination by assessing target and pathway inhibition
The duration of the study will include a period for screening of up to a maximum of 28 days, a pretreatment evaluation period of up to 5 days, the on-treatment period, followed by a minimum of 30-day follow-up after the last study drug administration. The patient may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. The study will have 2 parts: * Part one - Dose Escalation * Part Two - Expansion. At the defined maximum tolerated doses (MTD(s), additional patients will be enrolled to collect safety, Pharmacokinetic, and Pharmacodynamic data
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
18
Pharmaceutical form:capsule and tablet Route of administration: oral
Pharmaceutical form:capsule Route of administration: oral
Investigational Site Number 840001
Boston, Massachusetts, United States
Investigational Site Number 840002
Boston, Massachusetts, United States
Investigational Site Number 840003
Nashville, Tennessee, United States
Identification of maximum tolerated dose
Time frame: up to 4 years
Number of participants with treatment emergent adverse events
Time frame: up to 4 years
Pharmakokinetic parameters of SAR245408: Cmax
Time frame: up to 4 years
Pharmakokinetic parameters of SAR245408: Tmax
Time frame: up to 4 years
Pharmakokinetic parameters of SAR245408:AUCι
Time frame: up to 4 years
Pharmakokinetic parameters of MSC1936369B: Cmax
Time frame: up to 4 years
Pharmakokinetic parameters of MSC1936369B: Tmax
Time frame: up to 4 years
Pharmakokinetic parameters of MSC1936369B: AUCι
Time frame: up to 4 years
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