A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment
- Conditions
- Thyroid NeoplasmsCarcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT05241834
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1B: LOXO-260 Dose Expansion LOXO-260 LOXO-260 administered orally Phase 1A: LOXO-260 Dose Escalation LOXO-260 LOXO-260 administered orally
- Primary Outcome Measures
Name Time Method Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate During the first 28-day cycle of LOXO-260 treatment DLT rate
- Secondary Outcome Measures
Name Time Method Phase 1b: To assess the antitumor activity: Overall response rate (ORR) Up to approximately 24 months or 2 years ORR per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
To characterize the PK properties of LOXO-260: Mean concentration of LOXO-260 Up to approximately 24 months or 2 years PK: Mean concentration of LOXO-260
To assess the antitumor activity of LOXO-260: ORR Up to approximately 24 months or 2 years ORR per RECIST 1.1
Trial Locations
- Locations (16)
UCSF Medical Center at Mission Bay
🇺🇸San Francisco, California, United States
Centre Leon Berard
🇫🇷Lyon, Rhône-Alpes, France
Institut Gustave Roussy (Igr)
🇫🇷Villejuif, France
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Chicago Medicine-Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University Hospital
🇺🇸Columbus, Ohio, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States