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LY3300054

Phase 1

Solid Tumor | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Sep 27, 2024

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 Enrollment164
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02791334A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid TumorsPHASE1 COMPLETED 164Jun 29, 2016Jun 27, 2024Sep 27, 202414 United States, Belgium +5
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Study Endpoints
Primary Endpoints
Number of Participants with LY3300054 Dose Limiting Toxicities (DLTs)
Baseline through Cycle 1 (Approximately 28 Days)
Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3300054
Predose Cycle 1 Day 1 Through Follow Up (Approximately 6 Months)
PK: Cmax of Ramucirumab
Predose Cycle 1 Day 1 Through Follow Up (Approximately 6 Months)
PK: Cmax of Abemaciclib
Predose Cycle 1 Day 1 Through Follow Up (Approximately 6 Months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3300054EXPERIMENTALLY3300054 given intravenously (IV) on day 1 and day 15 of a 28 day cycle or LY3300054 given IV on day 1 of a 21 (or 28) day cycle.
LY3300054 + RamucirumabEXPERIMENTALLY3300054 and ramucirumab given IV on day 1 and day 15 of a 28 day cycle or ramucirumab given IV on day 1 and day 8 and LY3300054 given IV on day 1 of a 21 day cycle.
Abemaciclib + LY3300054EXPERIMENTALLY3300054 given IV on day 1 and day 15 and abemaciclib given orally every 12 hours of a 28 day cycle.
LY3300054 + Abemaciclib (Concurrent Dosing)EXPERIMENTALLY3300054 given IV on day 1 and day 15 and abemaciclib given orally every 12 hours of a 28 day cycle.
LY3300054 + AbemaciclibEXPERIMENTALLY3300054 given IV on day 1 and day 15 and abemaciclib given orally every 12 hours of a 28 day cycle. This arm will only be initiated if required.
LY3300054 + MerestinibEXPERIMENTALLY3300054 given IV on day 1 and day 15 and merestinib given orally once daily of a 28 day cycle.
LY3300054 Expansion (Metastatic Cutaneous Melanoma)EXPERIMENTALLY3300054 given IV on day 1 and day 15 of a 28 day cycle.
LY3300054 Expansion (MSI-H Solid Tumors)EXPERIMENTALLY3300054 given IV on day 1 and day 15 of a 28 day cycle.
: LY3300054 + Abemaciclib (HR+, HER2- Breast Cancer) ExpansionEXPERIMENTALLY3300054 given IV on day 1 and day 15 and abemaciclib given orally every 12 hours of a 28 day cycle.
LY3300054 + LY3321367 Expansion (PD-1/PD-L1 Naïve, MSI-H)EXPERIMENTALLY3300054 and LY3321367 given IV on day 1 and day 15 of a 28 day cycle.
LY3300054 + LY3321367 ExpansionEXPERIMENTALLY3300054 and LY3321367 given IV on day 1 and day 15 of a 28 day cycle.
LY3300054 + Merestinib (Pancreatic Cancer) ExpansionEXPERIMENTALLY3300054 given IV on day 1 and day 15 and merestinib given orally once daily of a 28 day cycle.
Interventions
NameTypeDescription
LY3300054DRUGAdministered IV
RamucirumabDRUGAdministered IV
AbemaciclibDRUGAdministered orally
MerestinibDRUGAdministered orally
LY3321367DRUGAdministered IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Histologic or cytologic confirmation of advanced solid tumor. * For LY3300054 + abemaciclib only: No participants with liver metastases. Participants must have normal aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin. * For LY3...

Countries:United StatesBelgiumCanadaFranceSouth KoreaSpainTaiwan
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