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SAR566658

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment114

FDA Designations

No designations recorded

Clinical trial landscape

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 Malignant
NCT01156870114
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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 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 small molecule being studied for the treatment of Neoplasm Malignant, a type of cancer. It is in Phase 1 clinical development and has been evaluated in patients with CA6-positive and refractory solid tumors.

What does SAR566658 target?

SAR566658 is designed to target CA6, a protein expressed on the surface of certain tumor cells. It is being developed as a potential therapy for patients with CA6-positive solid tumors that are refractory to existing treatments.

Who makes SAR566658?

SAR566658 is being developed by Sanofi, a global biopharmaceutical company. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.

What phase is SAR566658 in?

SAR566658 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 1 study has been completed to assess its safety and tolerability in patients with CA6-positive solid tumors.

What clinical trials is SAR566658 in?

SAR566658 has been studied in a Phase 1 clinical trial with the identifier NCT01156870. This first-in-human study enrolled 114 patients with CA6-positive and refractory solid tumors and was conducted in the United States, France, and Spain.

Is SAR566658 the same as any other drug?

SAR566658 is a unique investigational compound developed by Sanofi. No alternative names have been reported for this drug in clinical development.