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LEQ506

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

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 Tumors
NCT0110650857
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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 9 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about LEQ506

What is LEQ506 used for?

LEQ506 is an investigational small molecule being studied for the treatment of advanced solid tumors, including recurrent or refractory medulloblastoma and locally advanced or metastatic basal cell carcinoma. It is administered orally and is currently in clinical development for these oncology indications.

Who makes LEQ506?

LEQ506 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company sponsored the clinical trial of this investigational drug in patients with advanced solid tumors.

What phase is LEQ506 in?

LEQ506 is in Phase 1 clinical development. A Phase 1 dose-finding and safety study of oral LEQ506 in patients with advanced solid tumors has been completed. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is LEQ506 in?

LEQ506 has one completed clinical trial, registered as NCT01106508, titled "A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors." This Phase 1 study enrolled 57 participants across the United States, Netherlands, Switzerland, and United Kingdom.

Is LEQ506 FDA approved?

LEQ506 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for advanced solid tumors. The drug is still in clinical development and has not received marketing approval from the FDA or any other regulatory agency.