The Bi-steric, mTORC1-Selective Inhibitor, RMC-5552, in Advanced Solid Tumors: A Phase 1 Trial.

ABSTRACT:

Purpose

PI3K/mTOR pathway activation drives oncogenesis and progression of many cancers. RMC-5552 is a bi-steric, mTOR complex 1 (mTORC1)-selective inhibitor that potently inhibits phosphorylation of key mTORC1 substrates eukaryotic initiation factor 4E-binding protein-1 and S6 kinase and exhibits selectivity for mTORC1 over mTORC2. In this study, we report results from a first-in-human, dose-escalation study of RMC-5552 in patients with advanced solid tumors (NCT04774952).

Patients and methods

The safety, tolerability, pharmacokinetics, and preliminary activity of RMC-5552 (1.6-16 mg intravenous infusion weekly) were evaluated in 57 patients.

Results

The most common treatment-related adverse events were mucositis (49%), nausea (44%), and fatigue (42%). Consistent wit

SUBMITTER: Schram AM 

PROVIDER: S-EPMC12666311 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature