A Phase 1/2 Study of Oral LOXO-292 in Patients With Advanced Solid Tumors Including RET Fusion-Positive Solid Tumors Medullary Thyroid Cancer and Other Tumors With RET Activation (LIBRETTO-001)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Solid Tumors, Medullary Thyroid Cancer, And Other Tumors With Ret Activation
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Patients with a locally advanced or metastatic solid tumor who: • have progressed on or are intolerant to standard therapy, or • no standard therapy exists, or • in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or • decline standard therapy. 2) Prior MKI(s) with anti-RET activity are allowed. However, prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]) is prohibited 3) Archived tumor tissue sample available.

You may not be eligible for this study if the following are true:

  • 1) Phase 2, Cohorts 1-4, an additional validated oncogenic driver that could cause resistance to LOXO-292 treatment. 2) Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]) 3) Investigational agent or anticancer therapy within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of LOXO-292. In addition, no concurrent investigational anti-cancer therapy is permitted. Refer to the Protocol for allowable concurrent therapies 4) Major surgery (excluding placement of vascular access) within 4 weeks prior to planned start of LOXO-292.


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