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LEQ506

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Novartis AG|Trials Updated: Dec 17, 2020

LEQ506 development status

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

LEQ506 target and mechanism

Molecular targetSMO
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

LEQ506 clinical trials

LEQ506 · 1 trial · 3 indications

Phase 1 1
NCT01106508A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED57 Analytics
PHASE1COMPLETED
A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
21 day cycles

Secondary Endpoints

To characterize the safety and tolerability of LEQ506 treatment
21 day cycles
To characterize the pharmacokinetics of LEQ506
21 day cycles
To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples
21 day cycles
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LEQ506EXPERIMENTAL -

Interventions

NameTypeDescription
LEQ506DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma) * Protocol defined laboratory parameters * Performance status ≤ 2 * Patients must have fully recovered from the prior effects of major s...

Countries:United StatesNetherlandsSwitzerlandUnited Kingdom
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about LEQ506

What is LEQ506 used for?

LEQ506 is an investigational oral small molecule being studied in adults with advanced solid tumors, including recurrent or refractory medulloblastoma and locally advanced or metastatic basal cell carcinoma. It has been evaluated in a single Phase 1 dose-finding and safety study and is not an approved therapy.

What does LEQ506 target?

LEQ506 targets SMO, short for Smoothened, a component of the Hedgehog signaling pathway. LEQ506 acts as a SMO antagonist, meaning it is designed to block SMO activity. The Hedgehog pathway is implicated in several tumor types, including basal cell carcinoma and medulloblastoma.

Who makes LEQ506?

LEQ506 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 dose-finding and safety study of oral LEQ506 in patients with advanced solid tumors.

What phase is LEQ506 in?

LEQ506 is in Phase 1 clinical development. It is investigational and has not been approved for any indication. The single Phase 1 trial of LEQ506 has completed, and no active trials of the drug are currently listed.

What clinical trials is LEQ506 in?

LEQ506 has been studied in one completed Phase 1 trial, NCT01106508, titled A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors. It enrolled 57 adults across the United States, Netherlands, Switzerland, and the United Kingdom, and was an uncontrolled study without randomization or blinding.