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LOXO-260

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

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)

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 for the treatment of non-small-cell lung carcinoma and thyroid neoplasms. It is intended for cancer patients who have a change in the RET gene that has not responded to prior treatment. The drug is currently in Phase 1 clinical development.

What does LOXO-260 target?

LOXO-260 targets cancers driven by alterations in the RET gene. It is designed for patients whose tumors have a RET gene change that has not responded to previous therapy. The drug is being evaluated in a Phase 1 clinical trial for its safety and efficacy in this patient population.

Who makes LOXO-260?

LOXO-260 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical development for the treatment of RET-altered cancers, including non-small-cell lung carcinoma and thyroid neoplasms.

What phase is LOXO-260 in?

LOXO-260 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial, which has been completed, enrolled 70 participants and was conducted in the United States and France.

What clinical trials is LOXO-260 in?

LOXO-260 has one completed Phase 1 clinical trial, identified as NCT05241834. The study, titled 'A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment,' enrolled 70 participants with non-small-cell lung carcinoma and thyroid neoplasms. The trial was conducted in the United States and France.

Is LOXO-260 the same as any other drug?

LOXO-260 is the primary name used for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information. It is being developed by Eli Lilly and Company for the treatment of RET-altered cancers.