A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment
NCT ID: NCT05241834
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
70 participants
INTERVENTIONAL
2022-03-23
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1A: LOXO-260 Dose Escalation
LOXO-260 administered orally
LOXO-260
Oral
Phase 1B: LOXO-260 Dose Expansion
LOXO-260 administered orally
LOXO-260
Oral
Interventions
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LOXO-260
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Emin Avsar
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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UCLA Medical Center
Los Angeles, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
University of Chicago Medicine-Comprehensive Cancer Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Hospital
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Centre Leon Berard
Lyon, , France
Institut Gustave Roussy (Igr)
Villejuif, , France
Countries
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Related Links
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A Study of LOXO-260 in Cancer Patients with a Change in a Particular Gene (RET) that has not Responded to Treatment
Other Identifiers
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J3T-OX-JZTA
Identifier Type: OTHER
Identifier Source: secondary_id
LOXO-NGR-21001
Identifier Type: OTHER
Identifier Source: secondary_id
18381
Identifier Type: -
Identifier Source: org_study_id
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