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LY3300054

Phase 1

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

LY3300054 development status

Highest phase Phase 1
Registered trials 4 across 1 sponsor since Jun 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment164

FDA Designations

No designations recorded

LY3300054 clinical trials

LY3300054 · 1 trial · 5 indications

Phase 1 1
NCT02791334A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid TumorsSolid Tumor
COMPLETED164 Analytics
PHASE1COMPLETED
A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors
Solid TumorUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumor")

Frequently asked questions about LY3300054

What is LY3300054?

LY3300054 is an investigational anti-PD-L1 checkpoint antibody being developed by Eli Lilly and Company for advanced refractory solid tumors. It was studied both as a single agent and in combination with other therapies in a Phase 1 clinical trial. It is not yet approved and remains in clinical development.

What is LY3300054 used for?

LY3300054 was studied in adults with advanced refractory solid tumors, including microsatellite instability-high (MSI-H) solid tumors, cutaneous melanoma, pancreatic cancer, and HR+HER2- breast cancer. The trial enrolled participants whose tumors had progressed despite prior treatment. It is investigational and has not been approved for any indication.

Who makes LY3300054?

LY3300054 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study evaluating the agent alone and in combination in participants with advanced refractory solid tumors.

What phase is LY3300054 in?

LY3300054 is in Phase 1 development. Its single registered trial, NCT02791334, was a Phase 1 study that has been completed, with 164 participants enrolled. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is LY3300054 in?

LY3300054 was evaluated in one Phase 1 trial, NCT02791334, titled a study of anti-PD-L1 checkpoint antibody LY3300054 alone and in combination in participants with advanced refractory solid tumors. The trial enrolled 164 participants across the United States, Belgium, Canada, France, South Korea, Spain, and Taiwan, and it is now completed.

How does LY3300054 work?

LY3300054 is an anti-PD-L1 checkpoint antibody. It targets the PD-L1 immune checkpoint protein, which tumor cells use to suppress T-cell activity. By binding PD-L1, the antibody is designed to block this inhibitory signal and restore the immune system's ability to recognize and attack tumor cells.