Condition: Breast Cancer · Solid Tumors, Adult · Sponsor: Eli Lilly and Company
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant, tamoxifen, or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.
This description comes directly from the study's public registry record.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
Always discuss trial participation with your own doctor first.
| Ellison Clinic at Saint John's | Los Angeles, California, United States | Recruiting |
| UCSF Medical Center at Mission Bay | San Francisco, California, United States | Recruiting |
| University of Colorado Cancer Center | Aurora, Colorado, United States | Recruiting |
| Yale-New Haven Hospital | New Haven, Connecticut, United States | Completed |
| Florida Cancer Specialists ORLANDO/DDU | Lake Mary, Florida, United States | Completed |
| Moffitt Cancer Center | Tampa, Florida, United States | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta, Georgia, United States | Recruiting |
| University of Iowa | Iowa City, Iowa, United States | Recruiting |
| Louisiana State University Health Sciences Center | New Orleans, Louisiana, United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, United States | Terminated |
+ 53 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05768139