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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.

Tracking Information
First Submitted Date  ICMJE February 10, 2023
First Posted Date  ICMJE February 21, 2023
Last Update Posted Date November 21, 2023
Actual Study Start Date  ICMJE March 20, 2023
Estimated Primary Completion Date August 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2023)
  • Phase 1: Number of Patients who Experience Dose-Limiting Toxicity [ Time Frame: 21 Days ]
  • Phase 1/1b: Number of patients who experience a treatment-related adverse event [ Time Frame: Up to 2 years ]
  • Phase 2: Objective response rate (ORR) [ Time Frame: 2 years ]
  • Phase 2: Duration of response (DOR) [ Time Frame: 2 years ]
  • Phase 2: Progression free survival (PFS) [ Time Frame: 2 years ]
  • Phase 2: Overall survival (OS) [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2023)
  • Area under plasma concentration versus time curve (AUC) [ Time Frame: up to 4 days ]
  • Time to achieve maximal plasma concentration (Tmax) [ Time Frame: up to 4 days ]
  • Maximum observed plasma concentration (Cmax) [ Time Frame: up to 4 days ]
  • Terminal elimination half-life (t1/2) [ Time Frame: up to 4 days ]
  • Apparent total plasma clearance when dosed orally (CL/F) [ Time Frame: up to 4 days ]
  • Apparent volume of distribution when dosed orally (Vz/F) [ Time Frame: up to 4 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Official Title  ICMJE A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Brief Summary A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Advanced Solid Tumor
  • Non-small Cell Lung Cancer
  • Colo-rectal Cancer
  • Pancreatic Adenocarcinoma
Intervention  ICMJE Drug: MRTX1133
KRAS G12D Inhibitor
Study Arms  ICMJE
  • Experimental: Phase 1/1B
    Dose Escalation/Evaluation
    Intervention: Drug: MRTX1133
  • 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
    Intervention: Drug: MRTX1133
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 17, 2023)		 386
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2023)		 304
Estimated Study Completion Date  ICMJE August 30, 2026
Estimated Primary Completion Date August 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mirati Therapeutics Study Locator Services 18448935530 miratistudylocator@careboxhealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05737706
Other Study ID Numbers  ICMJE 1133-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mirati Therapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mirati Therapeutics Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hirak Der-Torossian, MD Mirati Therapeutics Inc.
PRS Account Mirati Therapeutics Inc.
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP