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Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

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: NCT05737706
Recruitment Status : Recruiting
First Posted : February 21, 2023
Last Update Posted : November 21, 2023
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Study Description
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Brief Summary:
A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.

Condition or disease Intervention/treatment Phase
Solid Tumor Advanced Solid Tumor Non-small Cell Lung Cancer Colo-rectal Cancer Pancreatic Adenocarcinoma Drug: MRTX1133 Phase 1 Phase 2

Detailed Description:
This first-in-human clinical trial will begin with an exploration of MRTX1133 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1133.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 386 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Actual Study Start Date : March 20, 2023
Estimated Primary Completion Date : August 30, 2026
Estimated Study Completion Date : August 30, 2026

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1/1B
Dose Escalation/Evaluation
 Drug: MRTX1133
KRAS G12D Inhibitor
Experimental: Phase 2
MRTX1133 recommended Phase 2 dose administered to separate cohorts of patients with selected solid tumor malignancies with KRAS G12D mutation to include the following: NSCLC, PDAC, CRC, Other Solid Tumors
 Drug: MRTX1133
KRAS G12D Inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1: Number of Patients who Experience Dose-Limiting Toxicity [ Time Frame: 21 Days ]
  2. Phase 1/1b: Number of patients who experience a treatment-related adverse event [ Time Frame: Up to 2 years ]
  3. Phase 2: Objective response rate (ORR) [ Time Frame: 2 years ]
  4. Phase 2: Duration of response (DOR) [ Time Frame: 2 years ]
  5. Phase 2: Progression free survival (PFS) [ Time Frame: 2 years ]
  6. Phase 2: Overall survival (OS) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Area under plasma concentration versus time curve (AUC) [ Time Frame: up to 4 days ]
  2. Time to achieve maximal plasma concentration (Tmax) [ Time Frame: up to 4 days ]
  3. Maximum observed plasma concentration (Cmax) [ Time Frame: up to 4 days ]
  4. Terminal elimination half-life (t1/2) [ Time Frame: up to 4 days ]
  5. Apparent total plasma clearance when dosed orally (CL/F) [ Time Frame: up to 4 days ]
  6. Apparent volume of distribution when dosed orally (Vz/F) [ Time Frame: up to 4 days ]

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 diagnosis of a solid tumor malignancy harboring KRAS G12D mutation in tumor tissue or ctDNA.
  • Unresectable or metastatic disease.
  • Patients must have received standard therapies appropriate for their tumor type and stage; first-line treatment for PDAC for certain cohorts.

  • Presence of tumor lesions to be evaluated per RECIST v1.1:

    1. in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease.
    2. in the Phase 1b and Phase 2 cohorts, patients must have measurable disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.
  • Age ≥ 18 years

Exclusion Criteria:

  • Active brain metastases or carcinomatous meningitis.
  • Prior treatment with a KRAS G12D inhibitor (Phase 1b & Phase 2 only).
  • History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow oral medications.
  • History of malignant small bowel obstruction.
  • Cardiac abnormalities.
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): NCT05737706


Contacts
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Contact: Mirati Therapeutics Study Locator Services 18448935530 miratistudylocator@careboxhealth.com

Locations
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United States, Arizona
Mayo Clinic Hospital Recruiting
Phoenix, Arizona, United States, 85054
United States, Connecticut
Yale University, Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Sarah Cannon Research Institute at Florida Cancer Specialists Recruiting
Orlando, Florida, United States, 32827
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
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
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10022
United States, Tennessee
SCRI - TN Oncology Nashville Drug Development Unit Clinic Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
NEXT Oncology Virginia Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Fred Hutchinson Cancer Center Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Mirati Therapeutics Inc.
Investigators
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Study Director: Hirak Der-Torossian, MD Mirati Therapeutics Inc.
More Information
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05737706    
Other Study ID Numbers: 1133-001
First Posted: February 21, 2023    Key Record Dates
Last Update Posted: November 21, 2023
Last Verified: November 2023

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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 Mirati Therapeutics Inc.:
Non-Small Cell Lung Cancer
NSCLC
colorectal cancer
CRC
PDAC
KRAS
 G12D
Solid Tumor
Advanced Solid Tumor
Malignant
Pancreatic Cancer
Pancreatic Adenocarcinoma
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type