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LGK974

Phase 1

Pancreatic Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Jun 13, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment185
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01351103A Study of LGK974 in Patients With Malignancies Dependent on Wnt LigandsPHASE1 COMPLETED 185Dec 1, 2011Jun 17, 2024Jun 13, 202520 United States, Canada +5
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Study Endpoints
Primary Endpoints
Incidence of dose limiting toxicities (DLTs) during the first cycle of LGK974 treatment and during the first 2 cycles of LGK974 in combination with PDR001
28 days (LGK974 single agent) and 56 days (LGK974 in combination with PDR001)

DLT is defined as an adverse event or abnormal laboratory value that is assessed by the investigator as unrelated to disease, disease progression, intercurrent illness, or concomitant medications and that meets the criteria defined in the study protocol. The objective was to determine the Maximum Tolerated Dose (MTD) or Recommended Dose for Expansion (RDE) of LGK974 as a single agent and in combination with PDR001 when administered orally to adult patients with malignancies dependent on Wnt ligands.

Secondary Endpoints
Type and category of study drug related adverse events (AE)
61 months
Absorption and plasma concentrations of LGK974
61 months
PD related to the Wnt pathway
61 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LGK974EXPERIMENTALLGK974
LGK974 in combination with PDR001EXPERIMENTALLGK in combination with PDR001
Interventions
NameTypeDescription
LGK974DRUG -
PDR001BIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: Diagnosis of locally advanced or metastatic cancer that has progressed despite standard therapy or for which no effective standard therapy exists and histological confirmation of one of the following diseases indicated below: Single Agent Dose escalation part:documented B-RAF m...

Countries:United StatesCanadaFranceGermanyItalyNetherlandsSpain
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Competitive Landscape -Pancreatic Cancer 186 trials
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