Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
- Registration Number
- NCT04774952
- Lead Sponsor
- Revolution Medicines, Inc.
- 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 relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).
- 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-Escalation Component for participants with relapsed or refractory solid tumors and 2) a Dose-Expansion Component for participants with relapsed or refractory solid tumors harboring certain specific mutations/rearrangements that result in hyperactivation of the mTOR pathway. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RMC-5552 RMC-5552 RMC-5552 for IV administration
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) up to 3 years Incidence, nature, and severity of treatment-emergent AEs and serious AEs, including incidence and severity of findings in laboratory values or vital signs for RMC-5552 monotherapy
Number of participants with dose limiting toxicities (DLTs) 21 days Incidence and nature of DLTs with RMC-5552 monotherapy
- Secondary Outcome Measures
Name Time Method Cmax up to 3 years Peak plasma concentration of RMC-5552
Tmax up to 3 years Time to achieve peak plasma concentration of RMC-5552
Area Under the Curve (AUC) up to 3 years Area under the plasma concentration time curve of RMC-5552
Overall Response Rate (ORR) up to 3 years Overall response rate of RMC-5552 per RECIST v1.1
Duration of Response (DOR) up to 3 years Duration of response of RMC-5552 per RECIST v1.1
t1/2 up to 3 years Elimination half-life of RMC-5552
Accumulation Ratio up to 3 years Ratio of accumulation of RMC-5552 from a single dose to steady state with repeated dosing
Trial Locations
- Locations (8)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Sarah Cannon Research Institute - Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
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
University of Oklahoma - Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Dell Seton Medical Center at University of Texas
🇺🇸Austin, Texas, United States