Back to resultsStudy of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Primary Purpose
Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MRTX1133
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor focused on measuring Non-Small Cell Lung Cancer, NSCLC, colorectal cancer, CRC, PDAC, KRAS, G12D, Solid Tumor, Advanced Solid Tumor, Malignant, Pancreatic Cancer, Pancreatic Adenocarcinoma
Eligibility 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: in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease. 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.
Sites / Locations
- Mayo Clinic HospitalRecruiting
- Yale University, Yale Cancer CenterRecruiting
- Sarah Cannon Research Institute at Florida Cancer SpecialistsRecruiting
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsRecruiting
- Massachusetts General HospitalRecruiting
- Dana-Farber Cancer InstituteRecruiting
- START MidwestRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- SCRI - TN Oncology Nashville Drug Development Unit ClinicRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
- NEXT OncologyRecruiting
- South Texas Accelerated Research Therapeutics, LLCRecruiting
- NEXT Oncology VirginiaRecruiting
- Fred Hutchinson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phase 1/1B
Phase 2
Arm Description
Dose Escalation/Evaluation
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
Outcomes
Primary Outcome Measures
Phase 1: Number of Patients who Experience Dose-Limiting Toxicity
Phase 1/1b: Number of patients who experience a treatment-related adverse event
Phase 2: Objective response rate (ORR)
Phase 2: Duration of response (DOR)
Phase 2: Progression free survival (PFS)
Phase 2: Overall survival (OS)
Secondary Outcome Measures
Area under plasma concentration versus time curve (AUC)
Time to achieve maximal plasma concentration (Tmax)
Maximum observed plasma concentration (Cmax)
Terminal elimination half-life (t1/2)
Apparent total plasma clearance when dosed orally (CL/F)
Apparent volume of distribution when dosed orally (Vz/F)
Full Information
NCT ID
NCT05737706
First Posted
February 10, 2023
Last Updated
August 25, 2023
Sponsor
Mirati Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05737706
Brief Title
Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Official Title
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
August 30, 2026 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirati Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 1/2, open-label, multicenter, study evaluating the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1133 in patients with advanced solid tumor malignancy 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer, Colo-rectal Cancer, Pancreatic Adenocarcinoma
Keywords
Non-Small Cell Lung Cancer, NSCLC, colorectal cancer, CRC, PDAC, KRAS, G12D, Solid Tumor, Advanced Solid Tumor, Malignant, Pancreatic Cancer, Pancreatic Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
304 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase 1/1B
Arm Type
Experimental
Arm Description
Dose Escalation/Evaluation
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
MRTX1133
Intervention Description
KRAS G12D Inhibitor
Primary Outcome Measure Information:
Title
Phase 1: Number of Patients who Experience Dose-Limiting Toxicity
Time Frame
21 Days
Title
Phase 1/1b: Number of patients who experience a treatment-related adverse event
Time Frame
Up to 2 years
Title
Phase 2: Objective response rate (ORR)
Time Frame
2 years
Title
Phase 2: Duration of response (DOR)
Time Frame
2 years
Title
Phase 2: Progression free survival (PFS)
Time Frame
2 years
Title
Phase 2: Overall survival (OS)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Area under plasma concentration versus time curve (AUC)
Time Frame
up to 4 days
Title
Time to achieve maximal plasma concentration (Tmax)
Time Frame
up to 4 days
Title
Maximum observed plasma concentration (Cmax)
Time Frame
up to 4 days
Title
Terminal elimination half-life (t1/2)
Time Frame
up to 4 days
Title
Apparent total plasma clearance when dosed orally (CL/F)
Time Frame
up to 4 days
Title
Apparent volume of distribution when dosed orally (Vz/F)
Time Frame
up to 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirati Therapeutics Study Locator Services
Phone
18448935530
Email
miratistudylocator@careboxhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicky Kang
Organizational Affiliation
Mirati Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University, Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute at Florida Cancer Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - TN Oncology Nashville Drug Development Unit Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
South Texas Accelerated Research Therapeutics, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Oncology Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
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