First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors (NCT05768139)
First-in-Human Study of STX-478, a Mutant-Selective PI3Kฮฑ Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Ellison Clinic at Saint John's โ Los Angeles, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (65 Sites)
Showing the first 25 of 65 sites.
- Ellison Clinic at Saint John's โ Los Angeles, California
- UCSF Medical Center at Mission Bay โ San Francisco, California
- University of Colorado Cancer Center โ Aurora, Colorado
- Yale-New Haven Hospital โ New Haven, Connecticut
- Florida Cancer Specialists ORLANDO/DDU โ Lake Mary, Florida
- Moffitt Cancer Center โ Tampa, Florida
- Winship Cancer Institute, Emory University โ Atlanta, Georgia
- University of Iowa โ Iowa City, Iowa
- Louisiana State University Health Sciences Center โ New Orleans, Louisiana
- Massachusetts General Hospital โ Boston, Massachusetts
- Dana-Farber Cancer Institute โ Boston, Massachusetts
- Barbara Ann Karmanos Cancer Institute โ Detroit, Michigan
- START Midwest โ Grand Rapids, Michigan
- Saint Luke's Cancer Institute โ Kansas City, Missouri
- Washington University โ St Louis, Missouri
- Memorial Sloan Kettering Cancer Center โ New York, New York
- UH Cleveland Medical Center โ Cleveland, Ohio
- Stefanie Spielman Comprehensive Breast Center โ Columbus, Ohio
- Providence Cancer Institute Franz Clinic โ Portland, Oregon
- The West Clinic, PLLC dba West Cancer Center โ Germantown, Tennessee
- Sarah Cannon Research Institute โ Nashville, Tennessee
- Mary Crowley Cancer Research Center โ Dallas, Texas
- Texas Oncology-Baylor Charles A. Sammons Cancer Center โ Dallas, Texas
- University of Texas Southwestern โ Dallas, Texas
- University of Texas MD Anderson Cancer Center โ Houston, Texas
๐ Contact the Study Coordinator
Phone: (317) 615-4559
Email: LillyTrials@Lilly.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.