clinical trial · NCT05759949
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
PIK3CA MutationSolid Tumor, AdultHER2-negative Breast CancerBreast CancerMetastatic Breast CancerAdvanced Breast CancerUnresectable Solid TumorHormone Receptor Positive TumorRLY-5836FulvestrantPalbociclibRibociclibAbemaciclib
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).
started
Mar 29, 2023
primary completion
Mar 18, 2025
completion
Apr 11, 2025
last updated
May 16, 2025
official title
A First-in-Human Study of PI3Kα 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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol