CompletedPhase 1NCT04774952

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

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).

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

StatusCompleted
PhasePhase 1
U.S. locations8
SponsorRevolution Medicines, Inc.
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Inclusion 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 Exclusion 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.

04
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.

View original record ↗