First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
Status:
Not yet recruiting
Trial end date:
2026-01-13
Target enrollment:
Participant gender:
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).