A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-260. LOXO-260 may be used to treat cancer that has a change in a particular gene (known as the RET gene). Participation could last up to 24 months (2 years) and possibly longer if the disease does not get worse.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 21, 2026 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Drug: LOXO-260
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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 mutation (MTC or MEN2-associated cancers) that is a histological or a cytological proven diagnosis of locally advanced, unresectable and/or metastatic cancer and meet cohort-specific criteria.
- Have received a prior selective RET inhibitor.
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 (age \> 16 years), Karnofsky Performance Status (KPS) ≥ 80 (age \> 16 years), or Lansky Performance Status (LPS) ≥ 40% (age \< 16 years).
- Have discontinued all previous treatments for cancer with resolution of any significant AEs, and of all clinically significant toxic effects of prior locoregional therapy, surgery, radiotherapy, or systemic anticancer therapy.
- Have adequate organ function.
- Phase 1b expansion: Patients must have measurable disease per RECIST v 1.1.
- Phase 1b expansion: Molecular Pathology Results (including RET and other genes) from a sample, blood or tissue, taken on or after RET selective treatment.
- Disease suitable for local therapy administered with curative intent.
- Have an active fungal, bacterial, and/or active untreated viral infection.
- The patient has a serious pre-existing medical condition(s).
- Have symptomatic CNS malignancy or metastasis.
- Patients treated with drugs known to be strong inhibitors or inducers of cytochrome P450 3A (CYP3A).
- Progression of disease within 4 months of starting a prior selective RET inhibitor.
- Phase 1b expansion: Patients harboring known activating bypass alterations outside RET that may confer resistance to LOXO-260.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA Medical CenterLos Angeles, California
- UCSF Medical Center at Mission BaySan Francisco, California
- Emory UniversityAtlanta, Georgia
- University of Chicago Medicine-Comprehensive Cancer CenterChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University of North CarolinaChapel Hill, North Carolina
- Cleveland Clinic FoundationCleveland, Ohio
- Ohio State University HospitalColumbus, Ohio
- Thomas Jefferson UniversityPhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2026. Always confirm current availability with the study team.