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New pill targets Hard-to-Treat cancers after other drugs fail

NCT ID NCT05241834

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This early-stage trial is testing an oral drug called LOXO-260 in about 70 people with advanced cancers that have a specific change in the RET gene. The cancers have stopped responding to other targeted treatments. The study aims to find the safest dose and see if the drug can shrink tumors. Participation may last up to 2 years or longer if the disease does not worsen.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LOXO-260 (oral drug)
What this could lead to
If it works, this could provide a new treatment option for people with certain cancers that have stopped responding to other targeted therapies.
What could go wrong
This is an early, small Phase 1 trial focused on safety and dosing, so it is not yet clear if LOXO-260 will be effective. Side effects are unknown and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

70 people

The number who actually took part.

Started

Mar 2022

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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: * 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.

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Conditions

The condition(s) this trial relates to.

medullary thyroid gland carcinoma multiple endocrine neoplasia type 2 non-small cell lung carcinoma RET fusion positive cancer Thyroid Neoplasms thyroid tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung Thyroid neoplasms

Contacts and locations

Locations

  • Centre Leon Berard

    Lyon, 69008, France

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Emory University

    Atlanta, Georgia, 30329-5102, United States

  • Institut Gustave Roussy (Igr)

    Villejuif, 94805, France

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Ohio State University Hospital

    Columbus, Ohio, 43210-1257, United States

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158, United States

  • University of Chicago Medicine-Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27514, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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