First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Summary
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.
Timeline
- Start
- 2023-04-17
- Primary completion
- 2030-07
- Completion
- 2030-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | — | — |
| Subject | STX-478 | Small molecule | — | — |
| Background | Abemaciclib | Small molecule | — | — |
| Background | Anastrozole | Other / unclassified | — | — |
| Background | Exemestane | Small molecule | — | — |
| Background | Fulvestrant | Small molecule | — | — |
| Background | Imlunestrant | Small molecule | — | — |
| Background | Letrozole | Other / unclassified | — | — |
| Background | Palbociclib | Small molecule | — | — |
| Background | Ribociclib | Small molecule | — | — |
| Background | Tamoxifen | Small molecule | — | — |