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LOXO-338

Phase 1

Leukemia, Lymphocytic, Chronic, B-Cell | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jul 17, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

LOXO-338 · 1 trial · 7 indications

Phase 1 1
NCT05024045Study of Oral LOXO-338 in Patients With Advanced Blood CancersLeukemia, Lymphocytic, Chronic, B-Cell
COMPLETED27 Analytics
PHASE1COMPLETED
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
Leukemia, Lymphocytic, Chronic, B-CellUnlock trial analytics

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 to 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)

MEDIUMAug 17, 2026NCT05024045TRIAL_REMOVED: changed
MEDIUMAug 17, 2026NCT05024045TRIAL_REMOVED: changed
MEDIUMAug 17, 2026NCT05024045TRIAL_REMOVED: changed
HIGHJul 17, 2026NCT05024045Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 17, 2026NCT05024045Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about LOXO-338

What is LOXO-338 used for?

LOXO-338 is an investigational small molecule being developed for the treatment of B-cell chronic lymphocytic leukemia and other advanced blood cancers, including B-cell marginal zone lymphoma, non-Hodgkin lymphoma, multiple myeloma, Waldenstrom macroglobulinemia, and mantle-cell lymphoma.

Who makes LOXO-338?

LOXO-338 is being developed by Eli Lilly and Company (NYSE: LLY). The drug is currently in Phase 1 clinical development for oncology indications.

What phase is LOXO-338 in?

LOXO-338 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study of the oral drug in patients with advanced blood cancers has been completed.

What clinical trials is LOXO-338 in?

LOXO-338 has one completed Phase 1 clinical trial, NCT05024045, titled "Study of Oral LOXO-338 in Patients With Advanced Blood Cancers." The trial enrolled 27 participants across the United States, France, Italy, and Poland.

Is LOXO-338 the same as any other drug?

No alternative names for LOXO-338 have been disclosed. The drug is identified by its investigational code name LOXO-338 and is being developed by Eli Lilly and Company.