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LY3300054

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment164

FDA Designations

No designations recorded

Clinical trial landscape

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 9 trials (matched to "Solid Tumor")

Frequently asked questions about LY3300054

What is LY3300054 used for in solid tumors?

LY3300054 is an investigational small molecule being studied for the treatment of advanced refractory solid tumors, including microsatellite instability-high (MSI-H) solid tumors, cutaneous melanoma, pancreatic cancer, and breast cancer (HR+HER2-). It is currently in Phase 1 clinical development and is not yet approved.

What does LY3300054 target?

LY3300054 is an anti-PD-L1 checkpoint antibody. It targets the PD-L1 protein, which is involved in immune checkpoint pathways. By binding to PD-L1, it is designed to modulate the immune response against tumor cells. This mechanism is being evaluated in the context of advanced solid tumors.

Who makes LY3300054?

LY3300054 is developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research to evaluate this investigational therapy in patients with advanced refractory solid tumors.

What phase is LY3300054 in?

LY3300054 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 study has been completed, and the drug is no longer in active clinical trials according to the available data.

What clinical trials is LY3300054 in?

LY3300054 has been studied in one clinical trial, identified as NCT02791334. This Phase 1 study evaluated the drug alone and in combination in participants with advanced refractory solid tumors. The trial has been completed and enrolled 164 participants across multiple countries.

Is LY3300054 the same as an anti-PD-L1 antibody?

Yes, LY3300054 is an anti-PD-L1 checkpoint antibody. It is designed to target PD-L1, a protein that can help tumors evade the immune system. This investigational drug is being developed for use in oncology, specifically for advanced solid tumors, and is currently in Phase 1 trials.