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SAR566658

Phase 1

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

SAR566658 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2010

SAR566658 target and mechanism

Molecular targetTUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, TUBA1A
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment114

FDA Designations

No designations recorded

SAR566658 clinical trials

SAR566658 · 1 trial · 1 indication

Phase 1 1
NCT01156870First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid TumorNeoplasm Malignant
COMPLETED114 Analytics
PHASE1COMPLETED
First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor
Neoplasm MalignantUnlock trial analytics

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 to 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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Frequently asked questions about SAR566658

What is SAR566658 used for?

SAR566658 is an investigational oncology drug studied in patients with CA6-positive refractory solid tumors, including malignant neoplasms. It was evaluated in a single Phase 1 first-in-man study of 114 patients across the United States, France, and Spain. It is not an approved therapy and remains in clinical development.

What does SAR566658 target?

SAR566658 is a small molecule inhibitor that targets tubulin proteins, specifically TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. By binding these tubulin subunits, it interferes with microtubule function in tumor cells. This target class places it among tubulin inhibitor chemotherapies.

Who is developing SAR566658?

SAR566658 is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored the Phase 1 first-in-man trial of the drug in patients with CA6-positive refractory solid tumors.

What phase is SAR566658 in?

SAR566658 is in Phase 1 development. Its only recorded clinical trial, NCT01156870, was a Phase 1 first-in-man study that has completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is SAR566658 in?

SAR566658 was studied in NCT01156870, titled First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor. This completed Phase 1 trial enrolled 114 patients aged 18 and older in the United States, France, and Spain. It was an uncontrolled, open-label study.