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Trial record 2 of 3 for:    RMC-6236
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Study of RMC-6291 in Combination With RMC-6236 in Participants With Advanced KRAS G12C Mutant Solid Tumors

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ClinicalTrials.gov Identifier: NCT06128551
Recruitment Status : Recruiting
First Posted : November 13, 2023
Last Update Posted : May 7, 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, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Colorectal Cancer Pancreatic Ductal Adenocarcinoma Drug: Assigned interventions Phase 1

Detailed Description:

This is an open-label, multicenter, Phase 1b study of RMC-6291 in combination with RMC-6236 in participants with advanced KRAS G12C-mutated solid tumors, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose and schedule (RP2DS) and provide a preliminary assessment of the antitumor activity of RMC-6291 in participants with KRASG12C tumors.

The study consists of two parts: Part 1 - Dose-Escalation and Part 2 Dose-Expansion.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination With RMC-6236 in Participants With Advanced KRAS G12C Mutant Solid Tumors
Actual Study Start Date : November 14, 2023
Estimated Primary Completion Date : November 30, 2026
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RMC-6291 and RMC-6236
Dose escalation and Dose expansion
 Drug: Assigned interventions
Drug: RMC-6291 and RMC-6236 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 vitals signs

  2. Dose Limiting Toxicities [ Time Frame: 21 days ]
    Number of participants with dose limiting toxicities


Secondary Outcome Measures :
  1. Maximum Observed Blood Concentration of RMC-6291 and RMC-6236 [ Time Frame: up to 21 weeks ]
    Cmax

  2. Time to Reach Maximum Blood Concentration of RMC-6291 and RMC-6236 [ Time Frame: up to 21 weeks ]
    Tmax

  3. Area Under Blood Concentration Time Curve of RMC-6291 and RMC-6236 [ Time Frame: up to 21 weeks ]
    AUC

  4. Elimination Half-Life of RMC-6291 and RMC-6236 [ Time Frame: up to 21 weeks ]
    t1/2

  5. Ratio of accumulation of RMC-6291 and RMC-6236 from a single dose to steady state with repeated dosing [ Time Frame: up to 21 weeks ]
    accumulation ratio

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

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

  8. Disease Control Rate [ Time Frame: up to 3 years ]
    Disease Control rate per RECIST v1.1

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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 125 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age

  • Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy

    1. Part 1. Dose Escalation: solid tumors, previously treated
    2. Part 2. Dose Expansion:

    i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors, ii. NSCLC, previously treated with immunotherapy and chemotherapy, naïve to KRAS G12C (OFF) inhibitors, iii. NSCLC, previously treated with immunotherapy, chemotherapy, with untreated, asymptomatic central nervous system (CNS) metastases <2 cm in size iv. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.

  • ECOG performance status 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Primary central nervous system (CNS) tumors
  • Active brain metastases
  • Known impairment of GI function that would alter the absorption
  • Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment
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): NCT06128551


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

Locations
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United States, California
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Stanford Cancer Institute Recruiting
Stanford, California, United States, 94305
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
NYU Langone Health Recruiting
New York, New York, United States, 10032
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
MD Anderson Recruiting
Houston, Texas, United States, 77030
NEXT Dallas Recruiting
Irving, Texas, United States, 75039
NEXT Oncology San Antonio Recruiting
San Antonio, Texas, United States, 78229
START Texas Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
NEXT Oncology Virginia Recruiting
Fairfax, Virginia, United States, 22031
Puerto Rico
Pan American Center for Oncology Trials Not yet recruiting
San Juan, Puerto Rico, 00935
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: NCT06128551    
Other Study ID Numbers: RMC-6291-101
First Posted: November 13, 2023    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
RMC-6236
RMC-6291
RAS (ON)
KRAS
KRASG12C
KRASG12C (ON)
Targeted therapy
Metastatic Cancer
Lung Cancer
Lung Neoplasms
Thoracic Neoplasms
Non-small Cell Lung Cancer
Carcinoma, Non-Small Cell Lung
NSCLC
Colorectal Cancer
 Colonic Neoplasms
CRC
Appendiceal Cancer
KRAS mutation
STK11/LKB1
KEAP1
Bronchial neoplasms
Respiratory tract neoplasms
Neoplasms by site
Neoplasms
Colon Cancer
Rectal Cancer
Lung disease
Respiratory tract diseases
Pancreatic Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
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