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

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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).

Key facts

Study ID

NCT04774952

Run by

Revolution Medicines, Inc.

People needed

58

Starts

2021-04-07

Expected to finish

2024-06-28

Last updated by the study team

2025-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Irvine - Chao Family Comprehensive Cancer Center — Irvine, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• UC San Francisco - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Oklahoma - Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Sarah Cannon Research Institute - Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Dell Seton Medical Center at University of Texas — Austin, Texas, United States

Full record on ClinicalTrials.gov

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