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LOXO-260

Phase 1

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Sep 4, 2025

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 Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05241834A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to TreatmentPHASE1 ACTIVE NOT_RECRUITING 70Mar 23, 2022Jun 1, 2026Sep 4, 202516 United States, France
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Study Endpoints
Primary Endpoints
Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate
During the first 28-day cycle of LOXO-260 treatment

DLT rate

Secondary Endpoints
Phase 1b: To assess the antitumor activity: Overall response rate (ORR)
Up to approximately 24 months or 2 years
To characterize the PK properties of LOXO-260: Mean concentration of LOXO-260
Up to approximately 24 months or 2 years
To assess the antitumor activity of LOXO-260: ORR
Up to approximately 24 months or 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1A: LOXO-260 Dose EscalationEXPERIMENTALLOXO-260 administered orally
Phase 1B: LOXO-260 Dose ExpansionEXPERIMENTALLOXO-260 administered orally
Interventions
NameTypeDescription
LOXO-260DRUGOral
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Must be ≥ 18 years of age at the time of signing the informed consent (Phase 1a and Phase 1b). Patients 12 years and older may be enrolled in Phase 1b for countries and sites where approved. * Must have evidence of a previously documented RET fusion (solid tumors) or RET mutat...

Countries:United StatesFrance
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05241834primaryCompletionDate: changed
LOWMay 24, 2026NCT05241834studyFirstPostDate: changed