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LOXO-338

Phase 1

Leukemia, Lymphocytic, Chronic, B-Cell | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Mar 3, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment316
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05024045Study of Oral LOXO-338 in Patients With Advanced Blood CancersPHASE1 ACTIVE NOT_RECRUITING 316Sep 30, 2021Jun 1, 2026Mar 3, 202623 United States, France +2
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Study Endpoints
Primary Endpoints
Part 1 - To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of oral LOXO-338
Cycle 1 (28 Days)

Measured by the number of patients with dose-limiting toxicities (DLTs)

Part 1 - To determine the effect of LOXO-338 on response rates
Estimated up to 2 years

Measured by the appropriate disease specified response criteria as appropriate to tumor type

Part 2 - To determine the safety and tolerability of LOXO-338 when given in combination with pirtobrutinib
Cycle 2 (28 Days)

Measured by the number of patients with dose-limiting toxicities (DLTs)

Secondary Endpoints
Part 1 - To characterize the pharmacokinetics (PK) properties of LOXO-338: Area under the plasma concentration versus time curve (AUC)
Predose up to 24 hours postdose
Part 1 - To characterize the PK properties of LOXO-338: Maximum drug concentration (Cmax)
Predose up to 24 hours postdose
Part 1 - To assess preliminary antitumor activity of LOXO-338 based on overall response rate (ORR)
Estimated up to 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LOXO-338 (Monotherapy)EXPERIMENTALLOXO-338 administered orally.
LOXO-338 + Pirtobrutinib (Combination)EXPERIMENTALLOXO-338 administered orally in combination with pirtobrutinib
Interventions
NameTypeDescription
LOXO-338DRUGOral
PirtobrutinibDRUGOral
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * B-cell malignancy. * Patients must have received prior therapy. * Patients must have an objective indication for therapy. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. * Anticipated life expectancy of greater than or equal to (≥) 12 weeks. * Adequat...

Countries:United StatesFranceItalyPoland
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05024045primaryCompletionDate: changed
LOWMay 24, 2026NCT05024045studyFirstPostDate: changed