Status:
COMPLETED
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
Lead Sponsor:
Revolution Medicines, Inc.
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 relaps...
Detailed Description
This is an open-label, multicenter, Phase 1/1b study of RMC-5552 monotherapy in participants with advanced relapsed or refractory solid tumors. The study will include 2 components: 1) a Dose-Escalatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2024
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04774952
Start Date
April 7 2021
End Date
June 28 2024
Last Update
April 15 2025
Active Locations (8)
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1
UC Irvine - Chao Family Comprehensive Cancer Center
Irvine, California, United States, 92868
2
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
3
UC San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612