First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Recruiting · Phase 1, Phase 2 · NCT05768139
Conditions: Breast Cancer, Solid Tumors, Adult
At a glance
- Research payments reported, 2025
- $25,864
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 880
About the trial
- Sponsor
- Eli Lilly and Company
- Tested
- STX-478 (drug), Fulvestrant (drug), Ribociclib (drug), Palbociclib (drug), Letrozole (drug), Anastrozole (drug), Exemestane (drug), Tamoxifen (drug), Abemaciclib (drug), Imlunestrant (drug), Metformin (drug)
- Dates
- Started 2023-04-17; completion 2030-07
- Results posted
- Not yet
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 Abemacicli…
From ClinicalTrials.gov, last updated 2026-07-07. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Eli Lilly and Company reported $25,864 in research payments for this study in 2025 (1 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.