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RMC-5552 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Revolution Medicines, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new drug, RMC-5552, to see if it is safe and effective in treating adults with solid tumors that have come back or haven't responded to other treatments.

Who is the study for?
Adults with advanced solid tumors that have not responded to standard treatments, or who can't tolerate them, are eligible. They must be over 18 years old, in fairly good health (ECOG status of 0-1), and have normal blood counts as well as liver and kidney function. Those with specific genetic changes in the mTOR pathway may also join.Check my eligibility
What is being tested?
The trial is testing different doses of a new cancer drug called RMC-5552 on its own to see how safe it is and how the body responds to it. The goal is to find the best dose for future studies by gradually increasing the amount given to participants.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, changes in blood sugar levels, mouth sores or inflammation (stomatitis/mucositis), fatigue, digestive issues like nausea or diarrhea, and potential impacts on heart or lung health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer has specific changes in the mTOR pathway.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events (AEs)
Number of participants with dose limiting toxicities (DLTs)
Secondary outcome measures
Accumulation Ratio
Area Under the Curve (AUC)
Cmax
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RMC-5552Experimental Treatment1 Intervention
RMC-5552 for IV administration

Find a Location

Who is running the clinical trial?

Revolution Medicines, Inc.Lead Sponsor
10 Previous Clinical Trials
1,954 Total Patients Enrolled
Revolution Medicines, IncStudy DirectorRevolution Medicines, Inc.

Media Library

RMC-5552 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04774952 — Phase 1
Solid Tumors Research Study Groups: RMC-5552
Solid Tumors Clinical Trial 2023: RMC-5552 Highlights & Side Effects. Trial Name: NCT04774952 — Phase 1
RMC-5552 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04774952 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this clinical experimentation?

"According to the clinicaltrials.gov listing, this medical trial is still open for enrollment and was initially published on April 7th 2021. The study has been updated most recently on August 9th 2022."

Answered by AI

Has the FDA sanctioned RMC-5552 for public use?

"Given the data available on RMC-5552, our estimations suggest its safety is at a level 1 due to it being in Phase 1 of clinical trials. This implies that there are only limited records indicating efficacy and security."

Answered by AI

How widespread is this trial's implementation?

"8 centres are currently signing up patients for the trial. These locations span from Nashville to Irvine and Sacramento, among other places. It is highly recommended that you select a nearby site in order to minimize travel demands if chosen as a participant."

Answered by AI

What is the primary goal of this experiment?

"The primary outcome measure of this trial, which will be tracked over the course of three years is dose limiting toxicities (DLTs). Additional endpoints include Cmax - the highest concentration of RMC-5552 in plasma, AUC - measuring how long it takes for RMC-5552 to reach peak concentrations and DOR - duration of response according to RECIST v1.1 standards."

Answered by AI

How many individuals are enrolled in this investigation?

"This clinical trial necessitates 108 patients that meet the eligibility criteria. Sarah Cannon Research Institute - Tennessee Oncology, PLLC in Nashville and UC Irvine - Chao Family Comprehensive Cancer Center in Irvine are two of many sites offering this study to willing participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
2021. "Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04774952.
~27 spots leftby Apr 2025
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