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Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

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ClinicalTrials.gov Identifier: NCT05462717
Recruitment Status : Recruiting
First Posted : July 18, 2022
Last Update Posted : December 1, 2023
Sponsor:
Information provided by (Responsible Party):
Revolution Medicines, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Colorectal Cancer (CRC) Pancreatic Ductal Adenocarcinoma Advanced Solid Tumor Drug: RMC-6291 Phase 1

Detailed Description:
This is an open-label, multicenter, Phase 1/1b study of RMC-6291 monotherapy in subjects with advanced KRASG12C-mutant solid tumors. The study will include 2 components: a Dose-Escalation and a Dose-Expansion. Subjects will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
Actual Study Start Date : September 19, 2022
Estimated Primary Completion Date : November 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: RMC-6291
Dose Escalation and Dose Expansion
 Drug: RMC-6291
Oral tablet once or twice a day


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events [ Time Frame: up to 3 years ]
    Number of participants with adverse events

  2. Dose Limiting Toxicities [ Time Frame: The first 21 days (i.e. Cycle 1) ]
    Number of participants with dose limiting toxicities


Secondary Outcome Measures :
  1. Maximum Observed Blood Concentration of RMC-6291 [ Time Frame: 7 Cycles ]
    Cmax

  2. Time to Reach Maximum Blood Concentration of RMC-6291 [ Time Frame: 7 Cycles ]
    Tmax

  3. Area Under Blood Concentration Time Curve of RMC-6291 [ Time Frame: 7 Cycles ]
    AUC

  4. Elimination Half-Life of RMC-6291 [ Time Frame: 7 Cycles ]
    t1/2

  5. Ratio of accumulation of RMC-6291 from a single dose to steady state with repeated dosing [ Time Frame: 7 Cycles ]
    accumulation ratio

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

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

  8. Disease Control Rate (DCR) [ Time Frame: 3 years ]
    Disease control rate per RECIST v1.1

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

  10. Progression-Free Survival (PFS) [ Time Frame: 3 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:

  • Subject must be ≥18 years of age.
  • Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments.
  • ECOG performance status 0 or 1
  • Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation
  • 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.
  • Prior therapy with KRASG12C (ON) inhibitor

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): NCT05462717


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

Locations
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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: NCT05462717    
Other Study ID Numbers: RMC-6291-001
First Posted: July 18, 2022    Key Record Dates
Last Update Posted: December 1, 2023
Last Verified: October 2023
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-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
Carcinoma, Pancreatic Ductal
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