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SAR566658

Phase 1

Neoplasm Malignant | Small molecule | Oncology |Sanofi|Last Updated: May 10, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment114
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01156870First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid TumorPHASE1 COMPLETED 114Sep 8, 2010Apr 7, 2017May 10, 20175 United States, France +1
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Study Endpoints
Primary Endpoints
Dose Escalation to determine the maximum tolerated dose (MTD) of SAR566658
3 weeks
Extension Cohorts to evaluate the preliminary anti-tumoral effect of SAR566658
Anticancer activity is assessed every 6 weeks
To assess the effect of SAR566658 at the recommended dose on CYP3A enzyme activity using midazolam as probe
At D1 and D4 of administration of SAR566658 for 24h of midazolam dosing
Secondary Endpoints
Overall safety profile based on adverse events reporting, laboratory tests, vital signs and specific pulmonary and ocular tests, according to the NCI-CTC AE v4.03
Up to 2 years
Pharmacokinetic (PK) parameters
Up to 2 years
Immunogenicity evaluation (anti-drug antibodies)
Up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAR566658EXPERIMENTALSAR566658 will be administered by intravenous (IV) infusion according to three different schedules
Interventions
NameTypeDescription
SAR566658DRUGPharmaceutical form:solution for infusion Route of administration: intravenous
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion criteria: Diagnosis of CA6-positive solid tumors as moderate to intense membrane staining of ≥15% of tumor cells for which no standard therapy is available. Exclusion criteria: * Eastem Cooperative Oncology Group performance status ≥2. * Any serious active disease or co-morbid condition...

Countries:United StatesFranceSpain
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