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LY3321367

Phase 1

Solid Tumor | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Oct 17, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment209

FDA Designations

No designations recorded

Clinical trial landscape

LY3321367 · 1 trial · 1 indication

Phase 1 1
NCT03099109A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid TumorsSolid Tumor
COMPLETED209 Analytics
PHASE1COMPLETED
A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with DLTs
Baseline through Cycle 1 (28 Day Cycle)

Dose Limiting Toxicity (DLT) is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.

Secondary Endpoints

PK: Cmax of LY3321367
Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)
PK: Cmax of LY3321367 in Combination with LY3300054
Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months)
ORR: Percentage of Participants With a CR or PR
Baseline to Measured Progressive Disease (Estimated up to 6 Months)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY3321367 Dose EscalationEXPERIMENTALLY3321367 given intravenously (IV).
LY3321367 + LY3300054 Dose EscalationEXPERIMENTALLY3321367 and LY3300054 given IV.
LY3321367 Dose ExpansionEXPERIMENTALLY3321367 given IV.
LY3321367 + LY3300054 Dose ExpansionEXPERIMENTALLY3321367 and LY3300054 given IV.
Japanese Arm D LY3321367EXPERIMENTALLY3321367 given IV.
Japanese Arm E LY3300054EXPERIMENTALLY3300054 given IV.
Japanese Arm F LY3321367 + LY3300054EXPERIMENTALLY3321367 and LY3300054 given IV.

Interventions

NameTypeDescription
LY3321367DRUGAdministered IV
LY3300054DRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * For Ph1a monotherapy and combination cohorts, histologic or cytologic confirmation of advanced solid tumor. * For Phase 1a and 1b, prior PD-1 or PD-L1 therapy or other immunotherapy is allowed, if the following criteria are met: * Must not have experienced a toxicity that l...

Countries:United StatesJapanSouth KoreaSpain
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about LY3321367

What is LY3321367 used for?

LY3321367 is an investigational small molecule being studied for the treatment of solid tumors. It is intended for patients with advanced relapsed or refractory solid tumors, meaning cancers that have not responded to prior treatment or have returned. The drug is currently in Phase 1 clinical development.

Who makes LY3321367?

LY3321367 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.

What phase is LY3321367 in?

LY3321367 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial has been completed, and the drug is not yet available for commercial use.

What clinical trials is LY3321367 in?

LY3321367 has been studied in one clinical trial with the identifier NCT03099109. This Phase 1 study evaluated LY3321367 alone or in combination with LY3300054 in participants with advanced relapsed or refractory solid tumors. The trial enrolled 209 participants and has been completed.

Is LY3321367 the same as LY3300054?

No, LY3321367 and LY3300054 are different drugs. LY3321367 is the investigational drug being studied, while LY3300054 is a separate agent that was tested in combination with LY3321367 in the clinical trial NCT03099109. The trial evaluated LY3321367 alone or with LY3300054 in patients with advanced solid tumors.