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First received: January 23, 2023

Clinical Trial: First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Study Status: Completed

Recruit Status: RECRUITING

Condition: PIK3CA Mutation

Study Type: INTERVENTIONAL


Official Title: A First-in-Human Study of PI3K? Inhibitor, RLY-5836, in Combination With Targeted and Endocrine Therapies in Participants With Advanced Breast Cancer and as a Single Agent in Advanced Solid Tumors

Brief Summary: This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment.The study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).

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