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LY4066434.

Phase 1

Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Eli Lilly and Company|Last Updated: May 26, 2026

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 Enrollment750
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06607185A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 750Oct 21, 2024Jan 1, 2030May 26, 202647 United States, Belgium +6
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Study Endpoints
Primary Endpoints
Number of Participants with Dose-limiting Toxicities (DLTs)
During the first cycle of LY4066434 treatment (up to 28 days)
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Up to approximately 5 years

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Secondary Endpoints
Overall Response Rate (ORR)
Up to approximately 5 years
Best Overall Response (BOR)
Up to approximately 5 years
Duration of Response (DOR)
Up to approximately 5 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY4066434 Monotherapy Dose EscalationEXPERIMENTALEscalating doses of LY4066434 administered orally.
LY4066434 Dose OptimizationEXPERIMENTALLY4066434 administered orally either alone or with another investigational agent.
Interventions
NameTypeDescription
LY4066434.DRUGAdministered orally.
CetuximabDRUGAdministered intravenously.
Nab paclitaxelDRUGAdministered intravenously.
GemcitabineDRUGAdministered intravenously.
OxaliplatinDRUGAdministered intravenously.
LeucovorinDRUGAdministered intravenously.
IrinotecanDRUGAdministered intravenously.
5FluorouracilDRUGAdministered intravenously.
CarboplatinDRUGAdministered intravenously.
CisplatinDRUGAdministered intravenously.
PemetrexedDRUGAdministered intravenously.
PembrolizumabDRUGAdministered intravenously.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: * Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA * Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer * Have measurable disease per RECIST 1.1 * H...

Countries:United StatesBelgiumFranceGermanyItalyJapanSpainTaiwan
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT06607185lastUpdatePostDate: changed
LOWMay 27, 2026NCT06607185lastUpdatePostDate: changed
LOWMay 26, 2026NCT06607185primaryCompletionDate: changed
LOWMay 24, 2026NCT06607185studyFirstPostDate: changed