Neoplasm Malignant Clinical Trial
Official title:
Phase I, Dose Escalation Study of Safety, Pharmacokinetic and Pharmacodynamic of SAR125844 Administered Weekly as Intravenous Infusion in Asian Adult Patients With Advanced Malignant Solid Tumors
Primary Objective:
In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844.
In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in
patients with measurable and MET gene amplification (including gastric cancer patients).
Secondary Objectives:
To characterize and confirm the global safety profile of SAR125844 including cumulative
toxicities.
To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic
effects (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore
the relationship of MET gene amplification status with antitumor effects.
To evaluate other pharmacodynamic biomarkers.
For both cohorts, escalation and expansion, the duration of the study for one patient will
include a period for inclusion of up to 3 weeks and a 4-week treatment cycle(s).The patient
may continue treatment until disease progression, unacceptable toxicity or willingness to
stop, followed by a minimum of 30-days follow-up.
If a patient treated in dose escalation part or in an expansion cohort, continues to benefit
from the treatment at the time of Clinical Study Report, the patient can continue study
treatment for a maximum of 1 year and will continue to undergo all assessments as per the
study flowchart. Such patients will be followed at least until 30 days after the last IMP
administration.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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