Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors

Study summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-5552 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRMC-5552

The study team can explain what participation involves.

Who it may be forRecurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 15, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Revolution Medicines, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Revolution Medicines, Inc.
Interventions being studied: Drug: RMC-5552

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Recurrent or relapsed→Resistant or refractory→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Participants (male or female) ≥18 years of age
Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments including approved drugs for oncogenic drivers in their tumor type
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Participants in the Dose-Expansion Component must have molecular aberrations in the mTOR pathway
Adequate hematologic, hepatic and renal function

Reasons someone may not be able to joinExclusion criteria

Known or suspected leptomeningeal or brain metastases or spinal cord compression
Primary central nervous system (CNS) tumors
Clinically significant cardiac disease
Active, clinically significant interstitial lung disease or pneumonitis
Subjects with abnormal fasting glucose, type 1 diabetes, or uncontrolled type 2 diabetes are excluded.
Subjects with stomatitis or mucositis of any grade

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

UC Irvine - Chao Family Comprehensive Cancer CenterIrvine, California
UC Davis Comprehensive Cancer CenterSacramento, California
UC San Francisco - Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
Moffitt Cancer CenterTampa, Florida
Memorial Sloan Kettering Cancer CenterNew York, New York
University of Oklahoma - Stephenson Cancer CenterOklahoma City, Oklahoma
Sarah Cannon Research Institute - Tennessee Oncology, PLLCNashville, Tennessee
Dell Seton Medical Center at University of TexasAustin, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 15, 2025. Always confirm current availability with the study team.

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