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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06040541
Recruitment Status : Recruiting
First Posted : September 15, 2023
Last Update Posted : February 1, 2024
Sponsor:
Information provided by (Responsible Party):
Revolution Medicines, Inc.

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Colorectal Cancer (CRC) Pancreatic Ductal Adenocarcinoma (PDAC) Advanced Solid Tumors Drug: RMC-9805 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG12D-Mutant Solid Tumors
Actual Study Start Date : September 7, 2023
Estimated Primary Completion Date : August 30, 2025
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RMC-9805
Dose exploration and dose expansion
 Drug: RMC-9805
Oral Tablets


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Dose Limiting Toxicities [ Time Frame: 21 days ]
    Number of participants with Dose Limiting Toxicities (DLTs)


Secondary Outcome Measures :
  1. Maximum Observed Blood Concentration (Cmax) of RMC-9805 [ Time Frame: up to 21 weeks ]
    Cmax

  2. Time to Reach Maximum Blood Concentration (Tmax) of RMC-9805 [ Time Frame: up to 21 weeks ]
    Tmax

  3. Area Under Blood Concentration Time Curve (AUC) of RMC-9805 [ Time Frame: up to 21 weeks ]
    AUC

  4. 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

  5. Elimination Half-Life (t1/2) of RMC-9805 [ Time Frame: up to 21 weeks ]
    t1/2

  6. Overall Response Rate (ORR) [ Time Frame: up to 3 years ]
    Assess per RECIST v1.1

  7. Duration of Response (DOR) [ Time Frame: up to 3 years ]
    Assess per RECIST v1.1

  8. Disease Control Rate (DCR) [ Time Frame: up to 3 years ]
    Assess per RECIST v1.1

  9. Time to Response (TTR) [ Time Frame: up to 3 years ]
    Assess per RECIST v1.1

  10. Progression-Free Survival (PFS) [ Time Frame: up to 3 years ]
    Assess per RECIST v1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040541


Contacts
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Contact: Revolution Medicines, Inc. (650) 779-2300 CT-inquiries@RevMed.com

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
START Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
NEXT Oncology Virginia Recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Revolution Medicines, Inc.
Investigators
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Study Director: Revolution Medicines, Inc. Revolution Medicines, Inc.
More Information
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Responsible Party: Revolution Medicines, Inc.
ClinicalTrials.gov Identifier: NCT06040541    
Other Study ID Numbers: RMC-9805-001
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: February 1, 2024
Last Verified: September 2023

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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
Keywords provided by Revolution Medicines, Inc.:
KRAS G12D (ON)
NSCLC
CRC
PDAC
Non-small Cell Lung Cancer
Lung Cancer
Colorectal Cancer
Colon Cancer
 Pancreatic Cancer
Metastatic Cancer
Pancreatic Ductal Adenocarcinoma
Pancreatic Neoplasms
Colorectal Neoplasms
Gastrointestinal Neoplasms
KRAS
Colonic Neoplasms
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type