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LY3164530

Phase 1

Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Oct 23, 2019

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 Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02221882A Study of LY3164530 in Participants With CancerPHASE1 COMPLETED 29Aug 1, 2014Mar 7, 2017Oct 23, 20193 United States
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Study Endpoints
Primary Endpoints
Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)
Cycle 1 (Cycle = 28 days)

Recommended Phase 2 Dose of LY3164530: MTD

Secondary Endpoints
Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3164530EXPERIMENTALLY3164530 in escalating dose cohorts given intravenously (IV) once on Days 1 and 15 or on Days 1, 8, 15, and 22 of a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Interventions
NameTypeDescription
LY3164530DRUGAdministered IV.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria * Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy. * Have adequate organ function. * Prior Treatments: * Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of ther...

Countries:United States
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