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Trial record 1 of 3 for:    RMC-6236
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Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

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ClinicalTrials.gov Identifier: NCT05379985
Recruitment Status : Recruiting
First Posted : May 18, 2022
Last Update Posted : February 23, 2024
Sponsor:
Information provided by (Responsible Party):
Revolution Medicines, Inc.

Study Description
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Brief Summary:
Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced 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-6236 Phase 1

Detailed Description:
This is a Phase 1/1b, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated patient population groups. RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 474 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Actual Study Start Date : May 31, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: RMC-6236

Enrollment into dose exploration may be from any advanced solid tumor type with KRAS p.G12 mutations.

Enrollment into dose expansion/optimization may be from groups consisting of patients with a single histotype/genotype (for example, KRAS G12-mutated NSCLC, PDAC, CRC, RAS mutant NSCLC, PDAC, CRC, Melanoma, gynecological cancer or other solid tumors not previously specified).

RAS mutant is defined as any nonsynonymous mutation of KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61)

 Drug: RMC-6236
Oral Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs, including incidence and severity of findings in laboratory values and vital signs [ Time Frame: up to 2.5 years ]
  2. Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Maximum Observed Blood Concentration (Cmax) of RMC-6236 [ Time Frame: up to 15 weeks ]
  2. Time to Reach Maximum Blood Concentration (Tmax) of RMC-6236 [ Time Frame: up to 15 weeks ]
  3. Area Under Blood Concentration Time Curve (AUC) of RMC-6236 [ Time Frame: up to 15 weeks ]
  4. Elimination Half-Life of RMC-6236 (t1/2) [ Time Frame: up to 15 weeks ]
  5. Ratio of accumulation of RMC-6236 from a single dose to steady state with repeated dosing [ Time Frame: up to 15 weeks ]
  6. Overall Response Rate (ORR) [ Time Frame: up to 2.5 years ]
    Overall response rate per RECIST v1.1

  7. Duration of Response (DOR) [ Time Frame: up to 2.5 years ]
    Duration of response per RECIST v1.1

  8. Disease Control Rate (DCR) [ Time Frame: up to 2.5 years ]
    Disease control rate per RECIST v1.1

  9. Time to Response (TTR) [ Time Frame: up to 2.5 years ]
    Time to response per RECIST v1.1

  10. Progression-Free Survival (PFS) [ Time Frame: up to 2.5 years ]
    Progression-free survival 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:

  • Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing.
  • Received prior standard therapy appropriate for tumor type and stage
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Primary central nervous system (CNS) tumors
  • Active, untreated brain metastases
  • Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
  • History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy

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): NCT05379985


Contacts
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Contact: Revolution Medicines, Inc. (650) 779-2300 rmc-6236_ct-inquiry@revmed.com

Locations
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United States, California
UC Irvine/Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
UCLA Recruiting
Santa Monica, California, United States, 90404
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Perlmutter Cancer Center at NYU Langone Health Recruiting
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Columbia University Recruiting
New York, New York, United States, 10032
United States, Ohio
Christ Hospital Cancer Center Recruiting
Cincinnati, Ohio, United States, 45219
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Next Oncology Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
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: NCT05379985    
Other Study ID Numbers: RMC-6236-001
First Posted: May 18, 2022    Key Record Dates
Last Update Posted: February 23, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Revolution Medicines, Inc.:
KRAS
Non-small Cell Lung Cancer
Lung Cancer
Colorectal Cancer
Colon Cancer
Metastatic Cancer
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
NSCLC
CRC
PDAC
Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
 Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplastic Processes
Thoracic Neoplasms
Antineoplastic Agents
Melanoma
Gynecological Cancers
RAS
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