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Monoclonal Antibodies

RMC-9805 for Solid Cancers

Phase 1
Recruiting
Research Sponsored by Revolution Medicines, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0 or 1
Pathologically documented, locally advanced or metastatic solid tumor malignancy with KRASG12D-mutations identified through DNA sequencing or PCR test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial evaluates if a new drug is safe and works for adults with certain types of cancer.

Who is the study for?
This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12D. Participants must have tried standard treatments without success or could not tolerate them, and should be in fairly good health (ECOG status 0 or 1) with their organs working well. People can't join if they have issues absorbing pills, brain tumors, active brain metastases, spinal cord compression, or previous treatment with similar investigational drugs.Check my eligibility
What is being tested?
The study tests the safety and how well people can handle RMC-9805 in those who have certain types of cancer like lung, colorectal, pancreatic cancer etc., all of which share the KRAS G12D mutation. The main goal is to see what happens when patients take this new drug.See study design
What are the potential side effects?
While the side effects are being studied as part of this trial's purpose and aren't fully known yet, potential risks may include typical reactions to cancer medications such as nausea, fatigue, liver problems among others depending on individual patient response.

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 is advanced or has spread, and tests show a KRASG12D mutation.
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My cancer has worsened or I couldn't tolerate the standard treatments.

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
Adverse events
Dose Limiting Toxicities
Secondary outcome measures
Area Under Blood Concentration Time Curve (AUC) of RMC-9805
Disease Control Rate (DCR)
Duration of Response (DOR)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RMC-9805Experimental Treatment1 Intervention
Dose exploration and dose expansion

Find a Location

Who is running the clinical trial?

Revolution Medicines, Inc.Lead Sponsor
10 Previous Clinical Trials
1,772 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA sanctioned RMC-9805 for public consumption?

"Our team at Power rated RMC-9805's safety a 1 due to it being in Phase 1 of the trial, which limits available data attesting its efficacy and security."

Answered by AI

How many participants are currently receiving treatment through this experimental protocol?

"Affirmative. According to clinicaltrials.gov, the trials that was initially made available on September 7th 2023 is currently searching for new participants. This research study requires 290 individuals at 2 medical facilities."

Answered by AI

Are there any available vacancies to participate in this research endeavor?

"As of the latest update on September 8th 2023, this clinical trial is still actively searching for individuals to participate. It was initially posted on September 7th 2023."

Answered by AI

What objectives are researchers hoping to achieve by conducting this research?

"This clinical trial aims to examine dose-limiting toxicities over a period of up to three years. Secondary outcome metrics include the time it takes for RMC-9805 levels in blood to reach maximum concentration (Tmax), area under this drug's curve concentrations (AUC) and ratios related to single doses versus steady state with repeated dosing over time (accumulation ratio)."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
University of Texas, MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have a presently incurable ultimately fatal disease. ’m inoperable.
PatientReceived 1 prior treatment
~193 spots leftby Aug 2025