A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumour Activity of SAR408701 in Patients With Advanced Solid Tumours
To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once
every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid
tumours (Escalation Phase).
To assess efficacy according to Response Evaluation Criteria in Solid Tumours 1.1 (RECIST
1.1) (Expansion Phase) of SAR408701 administered once every 2 weeks without a loading dose
at Cycle 1.
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.
View this trial on ClinicalTrials.gov
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