NCT04774952CompletedPhase 1
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
A Phase 1/1b, Open-Label, Multicenter, Dose-Escalation Study of RMC 5552 Monotherapy in Adult Subjects With Relapsed/Refractory Solid Tumors
Source: ClinicalTrials.gov · Last updated 15 Apr 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 25 Feb 2021
- Start date
- 7 Apr 2021
- Primary completion date
- 6 May 2024
- Lead sponsor
- Revolution Medicines, Inc.
- Diseases
- Bladder cancer, Melanoma, Cervical cancer, Lung cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT04774952
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 58
- From 7 Apr 2021 to the primary completion date, 6 May 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinically significant cardiac disease
- Active, clinically significant interstitial lung disease or pneumonitis
Lab values
- Subjects with abnormal fasting glucose, type 1 diabetes, or uncontrolled type 2 diabetes are excluded.
Other
- Known or suspected leptomeningeal or brain metastases or spinal cord compression
- Primary central nervous system (CNS) tumors
- Subjects with stomatitis or mucositis of any grade
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dell Seton Medical Center at University of Texas Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| UC Irvine - Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Sarah Cannon Research Institute - Tennessee Oncology, PLLC Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Oklahoma - Stephenson Cancer Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| UC Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| UC San Francisco - Helen Diller Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.