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LY3321367

Phase 1

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

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 Enrollment209
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03099109A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid TumorsPHASE1 COMPLETED 209 — — Apr 12, 2017Aug 30, 2023Oct 17, 202315 United States, Japan +2
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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 — 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
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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