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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2026
  • participants needed
    140
  • sponsor
    Eli Lilly and Company
Updated on 24 October 2022
RET

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.

Details
Condition Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms
Treatment LOXO-260
Clinical Study IdentifierNCT05241834
SponsorEli Lilly and Company
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

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 2 or 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

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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