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LM716

Phase 1

Neoplasms | Small molecule | Oncology |Novartis AG|Last Updated: Dec 17, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01911936A Phase I Study of LJM716 in Japanese Patients With Advanced Solid TumorsPHASE1 COMPLETED 12Sep 1, 2013Mar 1, 2015Dec 17, 20202 Japan
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Study Endpoints
Primary Endpoints
Incidence of dose-limiting toxicities (DLTs) in the dose escalation part
First cycle (28 days)
Secondary Endpoints
Frequency and severity of adverse events, number of and reasons for
from informed consent till 30 days after end of treatment
LJM716 serum concentration-time- profile and estimated PK
up to 10 cycle (1 cycle = 28 days)
Tumor response according to RECIST 1.1
every 2 months until end of treatment up to 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LJM716EXPERIMENTAL -
Interventions
NameTypeDescription
LM716DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Patients with the following indications: i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists: * For breast cancer: documented 3+ by immunohistochemistry, or ampl...

Countries:Japan
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