Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms, Solid tumors with RET alteration, Non-Small-Cell Lung Carcinoma, LOXO-260

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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 CAN'T join 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.

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94158 United States
  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of LOXO-260 in Cancer Patients with a Change in a Particular Gene (RET) that has not Responded to Treatment
ID
NCT05241834
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 110 study participants
Last Updated