Gender
All
Age Group
12 Years and up
Accepting 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.
