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LY3214996

Phase 1

Advanced Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Nov 22, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment210

FDA Designations

No designations recorded

Clinical trial landscape

LY3214996 · 2 trials · 5 indications

Phase 1 2
NCT04033341A Study of LY3214996 in Healthy ParticipantsHealthy
COMPLETED6 Analytics
NCT02857270A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic CancerAdvanced Cancer
COMPLETED210 Analytics
PHASE1COMPLETED
A Study of LY3214996 in Healthy Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Baseline through Day 8 after administration of study drug

Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Baseline through Day 8 after administration of study drug
Number of Participants with LY3214996 Dose Limiting Toxicities (DLTs)
Cycle 1 (21 Days)

Secondary Endpoints

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996
Predose through Day 8 after administration of study drug
PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996
Predose through Day 8 after administration of study drug
Total Number of Metabolites of LY3214996
Baseline through 48 hours after administration of study drug
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3214996 + [14C]-LY3214996EXPERIMENTALA single dose of LY3214996 and \[14C\]-LY3214996 administered orally.
LY3214996 Dose EscalationEXPERIMENTALLY3214996 given orally once a day (or twice a day) for 21 days.
LY3214996 + MidazolamEXPERIMENTAL(Preliminary Drug-Drug Interactions \[DDI\]) LY3214996 given orally (once a day) and midazolam given orally on cycle 1 day 1 and cycle 1 day 16 (21 day cycles except cycle 1 only = 22 days).
LY3214996 Dose ExpansionEXPERIMENTALLY3214996 given orally (once a day) during each 21 day cycle.
LY3214996 + AbemaciclibEXPERIMENTALDose Escalation and Expansion- LY3214996 given orally (dose timing will be determined) and abemaciclib given orally (single dose given during lead in period) twice a day every 12 hours during 21 day cycle.
LY3214996 + Nab-Paclitaxel + GemcitabineEXPERIMENTALDose Escalation and Expansion- LY3214996 given orally (dose timing will be determined) and nab-paclitaxel given intravenously (IV) on day 1, 8, and 15 and gemcitabine IV on day 1, 8, and 15 during each 28 day cycle.
LY3214996 + Encorafenib + CetuximabEXPERIMENTALDose Escalation and Expansion- LY3214996 given orally, encorafenib given orally and cetuximab given IV.
Japan Part 1EXPERIMENTALLY3214996 given orally.
Japan Part 2EXPERIMENTALLY3214996 given orally and abemaciclib given orally.

Interventions

NameTypeDescription
LY3214996DRUGAdministered orally
[14C]-LY3214996DRUGAdministered orally
MidazolamDRUGAdministered orally
AbemaciclibDRUGAdministered orally
Nab-paclitaxelDRUGAdministered IV
GemcitabineDRUGAdministered IV
EncorafenibDRUGAdministered orally
CetuximabDRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly health males * Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive Exclusion Criteria: * Females * Male participants sexually active with a pregnant partner * Are currently enrolled in a clinical study or have participated, within the ...

Countries:United StatesAustraliaFranceJapan
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about LY3214996

What is LY3214996 used for?

LY3214996 is an investigational small molecule being studied for the treatment of advanced cancer, including metastatic melanoma, metastatic non-small cell lung cancer, and colorectal cancer. It has also been evaluated in healthy participants. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

What does LY3214996 target?

LY3214996 is a small molecule designed to target specific pathways involved in cancer cell growth. It is being studied in advanced and metastatic cancers, including melanoma, non-small cell lung cancer, and colorectal cancer. The drug is in Phase 1 clinical trials to evaluate its safety and efficacy.

Who makes LY3214996?

LY3214996 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is currently in Phase 1 clinical development for advanced cancer and healthy participant studies.

What phase is LY3214996 in?

LY3214996 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA. Clinical trials are ongoing or completed to evaluate its safety and potential efficacy in advanced cancer and healthy participants.

What clinical trials is LY3214996 in?

LY3214996 has been studied in two completed Phase 1 clinical trials. NCT02857270 evaluated the drug alone or in combination with other agents in participants with advanced or metastatic cancer, enrolling 210 participants. NCT04033341 studied the drug in healthy male participants, enrolling 6 participants.

Is LY3214996 the same as any other drug?

LY3214996 is a unique investigational compound developed by Eli Lilly and Company. It is not known to be the same as any other marketed drug. It is being studied under its own name in clinical trials for advanced cancer and healthy participant studies.