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 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.
Official Title
First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Conditions
Breast Cancer
Solid Tumors, Adult
Intervention / Treatment
Drug: STX-478
Drug: Fulvestrant
Drug: Ribociclib
Drug: Palbociclib
Drug: Letrozole
Drug: Anastrozole
Drug: Exemestane
Other Study ID Numbers
- 27691
- J6M-OX-JSGA ( Other Identifier ) (OTHER: Eli Lilly and Company)
- STX-478-101 ( Other Identifier ) (OTHER: Scorpion Therapeutics, Inc)
- 2023-000442-41 ( EudraCT Number )
- 2023-504807-94
-00 ( EU Trial (CTIS) Number )
Learn more at: https://clinicaltrials.gov/study/NCT05768139?term=NCT05768139&rank=1