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

Schram AM, Meyerowitz JG et al. · 2025 · Clinical Cancer Research · Atlas ID SCH2025

What this study shows

First-in-human, open-label dose-escalation trial (n=57, advanced solid tumors, no comparator arm) of a bi-steric mTORC1-selective inhibitor. Treatment-related hyperglycemia was low (4%) and not dose-limiting, alongside a 64% disease control rate. Because the trial was uncontrolled and made no head-to-head comparison against rapamycin or an ATP-site inhibitor, this is encouraging early clinical evidence consistent with the hypothesis that sparing mTORC2 reduces metabolic toxicity -- it does not establish mTORC2 sparing as the cause.

Abstract

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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).

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At a glance

Evidence type H Human study Marked H because it is direct evidence from a human clinical trial or human cohort; the code names the kind of study, not its quality -- a small, well-run trial is still H.
Study type2 - Human Clinical Trial
Model systemHuman (Phase 1 dose escalation, n=57, advanced solid tumors, NCT04774952)
JournalClinical Cancer Research
Year2025
Peer reviewedYes
Record last updated2026-07-29
SourceDOI 10.1158/1078-0432.CCR-25-2112 · PMID 41056387 · Free full text (PMC12666311)

Extracted findings

InterventionRMC-5552 (bi-steric mTORC1-selective inhibitor), 1.6-16mg IV weekly
TargetmTORC1 (4E-BP1, S6K1), sparing mTORC2
ModelHuman
Effect64% disease control rate (uncontrolled); low (4%) treatment-related hyperglycemia, consistent with mTORC2 sparing

In the Atlas

Related topics

mTORC1mTORC2S6K14E-BP1

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Cite this paper

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Schram, A. M., et al. (2025). The Bi-steric, mTORC1-Selective Inhibitor, RMC-5552, in Advanced Solid Tumors: A Phase 1 Trial. Clinical Cancer Research. https://doi.org/10.1158/1078-0432.CCR-25-2112

@article{SCH2025,
  author       = {Schram, A. M. and Meyerowitz, J. G. and others},
  title        = {{The Bi-steric, mTORC1-Selective Inhibitor, RMC-5552, in Advanced Solid Tumors: A Phase 1 Trial}},
  journal      = {Clinical Cancer Research},
  year         = {2025},
  doi          = {10.1158/1078-0432.CCR-25-2112},
  note         = {PMID: 41056387},
}

Cite this Atlas record

The record is the Atlas's own work — the evidence label, the extracted findings and the links. It is cited as part of the dataset, not as the paper. 

Barton, O. (2026). Oliver's mTOR Atlas (record SCH2025) [Data set]. https://mtor-atlas.org/study/SCH2025/ · Dataset DOI 10.5281/zenodo.22059963

@misc{atlas_SCH2025,
  author       = {Barton, Oliver},
  title        = {{Oliver's mTOR Atlas}, record SCH2025},
  howpublished = {Data set},
  year         = {2026},
  url          = {https://mtor-atlas.org/study/SCH2025/},
  doi          = {10.5281/zenodo.22059963}
}