A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Resp… (NCT05241834) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment
United States70 participantsStarted 2022-03-23
Plain-language 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.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
What they're measuring
1
Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate
Timeframe: During the first 28-day cycle of LOXO-260 treatment