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LJM716

Phase 1

Advanced HER2-positive Breast Cancer or Gastric Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Dec 19, 2020

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01602406Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric CancerPHASE1 COMPLETED 64Sep 21, 2012Aug 2, 2017Dec 19, 202011 United States, Belgium +7
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Study Endpoints
Primary Endpoints
Incidence rate of Dose Limiting Toxicities
4 weeks

Incidence of dose-limiting toxicities (DLTs)

Secondary Endpoints
Number of adverse events
4 months
Number of serious adverse events
4 months
Pharmacodynamic response to LJM716 in tumor tissue
3 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LJM716 in combination with trastuzumabEXPERIMENTAL -
Interventions
NameTypeDescription
LJM716DRUGLJM716
TrastuzumabDRUGTrastuzumab
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Patients with confirmed HER-2 positive, metastatic or non-operable locally advanced breast or gastric cancer * Metastatic breast cancer patients must have received a minimum of 1 and a maximum of 3 prior anti HER2 based regimens with documented progression on the most recent r...

Countries:United StatesBelgiumFranceItalyNetherlandsSouth KoreaSpainTaiwanUnited Kingdom
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