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First received: March 01, 2023

Clinical Trial: First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Study Status: Completed

Recruit Status: RECRUITING

Condition: Breast Cancer

Study Type: INTERVENTIONAL


Official Title: First-in-Human Study of STX-478, a Mutant-Selective PI3K? Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Brief Summary: 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 advanced solid tumors and breast cancer; 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,…

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