Breast Cancer Clinical Trial
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 Tumor
Study STX-478-101 is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 in participants with advanced solid tumors with certain mutations. Part 1 will evaluate STX-478 as monotherapy in participants with breast cancer and other solid tumor types; Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX 478 monotherapy or combination therapy. Participants will remain in the study part to which they are initially enrolled throughout their participation in the study (i.e., they will not move into other study parts).
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