First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Breast Cancer, Solid Tumors, Adult
In brief
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.
Key facts
- Study ID
- NCT05768139
- Run by
- Eli Lilly and Company
- People needed
- 880
- Starts
- 2023-04-17
- Expected to finish
- 2030-07-01
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- START Mountain Region — West Valley City, Utah, United States (enrolling)
- USO-Virginia Cancer Specialists, PC — Fairfax, Virginia, United States (enrolling)
- UCSF Medical Center at Mission Bay — San Francisco, California, United States (enrolling)
- START San Antonio — San Antonio, Texas, United States (enrolling)
- University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
- Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (enrolling)
- University of Iowa — Iowa City, Iowa, United States (enrolling)
- Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Ellison Clinic at Saint John's — Los Angeles, California, United States (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- START Midwest — Grand Rapids, Michigan, United States (enrolling)
- Saint Luke's Cancer Institute — Kansas City, Missouri, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- UH Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
- Stefanie Spielman Comprehensive Breast Center — Columbus, Ohio, United States (enrolling)
- Providence Cancer Institute Franz Clinic — Portland, Oregon, United States (enrolling)
- The West Clinic, PLLC dba West Cancer Center — Germantown, Tennessee, United States (enrolling)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States (enrolling)
- University of Texas Southwestern — Dallas, Texas, United States (enrolling)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Institut Jules Bordet — Anderlecht, Belgium (enrolling)
Full record on ClinicalTrials.gov
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