Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
NCT ID: NCT04774952
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
58 participants
INTERVENTIONAL
2021-04-07
2024-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RMC-5552
RMC-5552 for IV administration
RMC-5552
RMC-5552 for IV administration
Interventions
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RMC-5552
RMC-5552 for IV administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Revolution Medicines, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Revolution Medicines, Inc
Role: STUDY_DIRECTOR
Revolution Medicines, Inc.
Locations
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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
Countries
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References
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Schram AM, Naqash AR, Haura EB, Riess JW, Ulahannan SV, Ou SI, Munster PN, Cheng ML, Gustafson WC, Bitman B, Friedman R, Penn R, Kar S, Seshadri V, Wang Z, Tao L, Yang YC, Singh M, Burris HA, Meyerowitz JG. The Bi-steric, mTORC1-Selective Inhibitor, RMC-5552, in Advanced Solid Tumors: A Phase 1 Trial. Clin Cancer Res. 2025 Oct 7. doi: 10.1158/1078-0432.CCR-25-2112. Online ahead of print.
Other Identifiers
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RMC-5552-001
Identifier Type: -
Identifier Source: org_study_id
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