Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors

January 31, 2024 updated by: Revolution Medicines, Inc.

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG12D-Mutant Solid Tumors

This study is to evaluate the safety and tolerability of RMC-9805 in adults with KRAS G12D-mutant solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, multicenter, Phase 1/1b study of RMC-9805, monotherapy, selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two parts: Part 1- Dose-Exploration and Part 2- Dose-Expansion.

Study Type

Interventional

Enrollment (Estimated)

290

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Carolina BioOncology Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Mary Crowley Cancer Research
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas, MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • START
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Next Oncology Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathologically documented, locally advanced or metastatic solid tumor malignancy with KRASG12D-mutations identified through deoxyribonucleic acid (DNA) sequencing or polymerase chain reaction (PCR) test
  • Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
  • ECOG performance status 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Primary central nervous system (CNS) tumors
  • Known or suspected leptomeningeal or active brain metastases or spinal cord compression
  • Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
  • Participant was previously treated with an investigational KRASG12D inhibitor or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)

Other inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RMC-9805
Dose exploration and dose expansion
Drug: RMC-9805
Oral Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Up to 3 years
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs
Up to 3 years
Dose Limiting Toxicities
Time Frame: 21 days
Number of participants with Dose Limiting Toxicities (DLTs)
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Blood Concentration (Cmax) of RMC-9805
Time Frame: up to 21 weeks
Cmax
up to 21 weeks
Time to Reach Maximum Blood Concentration (Tmax) of RMC-9805
Time Frame: up to 21 weeks
Tmax
up to 21 weeks
Area Under Blood Concentration Time Curve (AUC) of RMC-9805
Time Frame: up to 21 weeks
AUC
up to 21 weeks
Ratio of accumulation of RMC-9805 from a single dose to steady state with repeated dosing
Time Frame: up to 21 weeks
accumulation ratio of RMC-9805
up to 21 weeks
Elimination Half-Life (t1/2) of RMC-9805
Time Frame: up to 21 weeks
t1/2
up to 21 weeks
Overall Response Rate (ORR)
Time Frame: up to 3 years
Assess per RECIST v1.1
up to 3 years
Duration of Response (DOR)
Time Frame: up to 3 years
Assess per RECIST v1.1
up to 3 years
Disease Control Rate (DCR)
Time Frame: up to 3 years
Assess per RECIST v1.1
up to 3 years
Time to Response (TTR)
Time Frame: up to 3 years
Assess per RECIST v1.1
up to 3 years
Progression-Free Survival (PFS)
Time Frame: up to 3 years
Assess per RECIST v1.1
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revolution Medicines, Inc.

Investigators

  • Study Director: Revolution Medicines, Inc., Revolution Medicines, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2023

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC-9805-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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