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SAR428926

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

SAR428926 · 1 trial · 1 indication

Phase 1 1
NCT02575781A Study of SAR428926 in Patients With Advanced Solid TumorsNeoplasm Malignant
COMPLETED34 Analytics
PHASE1COMPLETED
A Study of SAR428926 in Patients With Advanced Solid Tumors
Neoplasm MalignantUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about SAR428926

What is SAR428926 used for?

SAR428926 is an investigational small molecule being studied for the treatment of Neoplasm Malignant, which refers to advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes SAR428926?

SAR428926 is being developed by Sanofi, a multinational pharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY.

What phase is SAR428926 in?

SAR428926 is in Phase 1 clinical development. It has completed one Phase 1 trial, and it remains an investigational drug that has not yet received regulatory approval.

What clinical trials is SAR428926 in?

SAR428926 has been studied in one clinical trial, identified as NCT02575781, titled 'A Study of SAR428926 in Patients With Advanced Solid Tumors.' This Phase 1 trial has been completed and enrolled 34 participants.

Is SAR428926 the same as any other drug?

No alternative names for SAR428926 have been reported. It is identified solely by its code name SAR428926 in clinical trial registries and scientific literature.