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LOXO-260

Phase 1

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Eli Lilly and Company|Trials Updated: Aug 21, 2026

LOXO-260 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Dec 2015

LOXO-260 target and mechanism

ModalitySmall molecule

Also known as LY3838915

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

LOXO-260 clinical trials

LOXO-260 · 1 trial · 2 indications

Phase 1 1
NCT05241834A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to TreatmentCarcinoma, Non-Small-Cell Lung
COMPLETED70 Analytics
PHASE1COMPLETED
A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment
Carcinoma, Non-Small-Cell LungUnlock trial analytics

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 to 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)

MEDIUMSep 21, 2026NCT05241834TRIAL_REMOVED: changed
MEDIUMSep 21, 2026NCT05241834TRIAL_REMOVED: changed
MEDIUMSep 21, 2026NCT05241834TRIAL_REMOVED: changed
HIGHAug 21, 2026NCT05241834Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHAug 21, 2026NCT05241834Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about LOXO-260

What is LOXO-260 used for?

LOXO-260 is an investigational small molecule being studied in cancer patients, including those with non-small-cell lung carcinoma and thyroid neoplasms. It is designed for patients whose tumors have a change in the RET gene and whose disease has not responded to prior treatment. It is not approved for any use.

Who makes LOXO-260?

LOXO-260 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The compound is part of Lilly's oncology pipeline and is being studied in a biomarker-selected patient population with RET-altered tumors.

What phase is LOXO-260 in?

LOXO-260 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 study has completed enrollment of 70 patients across the United States and France.

What clinical trials is LOXO-260 in?

LOXO-260 has been evaluated in the Phase 1 trial NCT05241834, titled A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment. The trial enrolled 70 patients, included sites in the United States and France, and is now completed.

What does LOXO-260 target?

LOXO-260 is a small molecule directed at RET, a gene that can carry alterations in certain cancers. The Phase 1 trial NCT05241834 selected patients whose tumors had a change in the RET gene and who had not responded to prior treatment, including those with non-small-cell lung carcinoma and thyroid neoplasms.

Is LOXO-260 FDA approved?

No. LOXO-260 is an investigational drug in Phase 1 clinical development and is not FDA approved. Its only listed trial, NCT05241834, has completed with 70 patients enrolled. Approval status would only change if the developer reports regulatory action, which has not occurred.