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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1A: LOXO-260 Dose Escalation 		LOXO-260 administered orally
  • Drug: LOXO-260
    Oral
    Other names:
    • LY3838915
Experimental
Phase 1B: LOXO-260 Dose Expansion 		LOXO-260 administered orally
  • Drug: LOXO-260
    Oral
    Other names:
    • LY3838915

More Details

Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.