A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment
A Phase 1 Study of Oral LOXO-260 in Patients With RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation Refractory to Selective RET Inhibitors
3 other identifiers
interventional
70
2 countries
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
Longer than P75 for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedStudy Start
First participant enrolled
March 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedSeptember 4, 2025
September 1, 2025
2.5 years
February 8, 2022
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate
DLT rate
During the first 28-day cycle of LOXO-260 treatment
Secondary Outcomes (3)
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
Study Arms (2)
Phase 1A: LOXO-260 Dose Escalation
EXPERIMENTALLOXO-260 administered orally
Phase 1B: LOXO-260 Dose Expansion
EXPERIMENTALLOXO-260 administered orally
Interventions
Oral
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
UCLA Medical Center
Los Angeles, California, 90095, United States
UCSF Medical Center at Mission Bay
San Francisco, California, 94158, United States
Emory University
Atlanta, Georgia, 30329-5102, United States
University of Chicago Medicine-Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Hospital
Columbus, Ohio, 43210-1257, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Centre Leon Berard
Lyon, 69008, France
Institut Gustave Roussy (Igr)
Villejuif, 94805, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emin Avsar
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 8, 2022
First Posted
February 16, 2022
Study Start
March 23, 2022
Primary Completion
September 17, 2024
Study Completion (Estimated)
June 1, 2026
Last Updated
September 4, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share