Recent Updates
Recently added Catalysts

SAR428926

Phase 1

Neoplasm Malignant | Small molecule | Oncology |Sanofi|Last Updated: Aug 22, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02575781A Study of SAR428926 in Patients With Advanced Solid TumorsPHASE1 COMPLETED 34Oct 5, 2015Jun 1, 2018Aug 22, 20183 Denmark, France +1
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of patients with dose limiting adverse events (Escalation cohort)
4 weeks
Number of patients with corneal adverse events impacting study treatment (Escalation cohort)
8 weeks
Assessment of overall response rate using standard imaging and RECIST v1.1 criteria (Expansion cohort)
Tumor assessment every 2 months until disease progression or up to 36 months, whichever came first
Secondary Endpoints
Number of treatment emergent adverse events
Up to 3 years
Assessment of PK parameter: maximum concentration (Cmax)
2 months
Assessment of PK parameter: time to reach maximum concentration (tmax)
2 months
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAR428926-Escalating cohortEXPERIMENTALSAR428926 will be administered intravenously up to disease progression or dose limiting toxicities
SAR428926 in triple negative breast cancer-Expansion Cohort 1EXPERIMENTALSAR428926 will be administered intravenously at maximum tolerated dose (MTD) up to disease progression or unacceptable toxicity
SAR428926 in solid tumors-Expansion Cohort 2EXPERIMENTALSAR428926 will be administered intravenously at the MTD up to disease progression or unacceptable toxicity
Interventions
NameTypeDescription
SAR428926DRUGPharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria : * Patients with advanced solid tumor with no standard alternative treatment. * Availability of archived tumor tissue for SAR428926 targeted antigen testing. * For participants in the Escalation Phase: human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC), ...

Countries:DenmarkFranceSpain
Unlock Eligibility Criteria