Trial Title:
Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
NCT ID:
NCT05737706
Condition:
Solid Tumor
Advanced Solid Tumor
Non-small Cell Lung Cancer
Colo-rectal Cancer
Pancreatic Adenocarcinoma
Conditions: Official terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Conditions: Keywords:
Non-Small Cell Lung Cancer
NSCLC
colorectal cancer
CRC
PDAC
KRAS
G12D
Solid Tumor
Advanced Solid Tumor
Malignant
Pancreatic Cancer
Pancreatic Adenocarcinoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MRTX1133
Description:
KRAS G12D Inhibitor
Arm group label:
Phase 1/1B
Arm group label:
Phase 2
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.
Criteria for 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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Hospital
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tanios Bekaii-Saab, Site 311
Phone:
480-301-8000
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06520 8028
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patricia LoRusso, Site 309
Phone:
313-745-6258
Facility:
Name:
Florida Cancer Specialists & Research Institute (FCS) - Villages East
Address:
City:
Lady Lake
Zip:
32159 8987
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cesar Perez Batista, Site 301
Facility:
Name:
John Hopkins Medicine - Hematology/oncology
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nilofer Azad, Site 306
Phone:
410-502-2995
Facility:
Name:
Massachusetts General Hospital (MGH)
Address:
City:
Boston
Zip:
02114 3117
Country:
United States
Status:
Recruiting
Contact:
Last name:
Colin Weekes, Site 308
Phone:
720-848-0030
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Haeseong Park, Site 310
Phone:
86640833243147471171
Facility:
Name:
South Texas Accelerated Research Therapeutics (START) - Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sreenivasa Chandana, Site 314
Phone:
269-993-6056
Facility:
Name:
Memorial Sloan-Kettering Cancer Center
Address:
City:
New York
Zip:
10065 6800
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yonina Murciano-Goroff, Site 312
Phone:
646-888-4226
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melissa Johnson, Site 303
Phone:
615-329-7274
Facility:
Name:
UT MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Hong, Site 302
Phone:
713-563-1930
Facility:
Name:
The START Center for Cancer Care
Address:
City:
San Antonio
Zip:
78229 3307
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kyriakos Papadopoulos, Site 304
Phone:
210-593-5258
Facility:
Name:
Next Oncology - Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anthony Tolcher, Site 313
Phone:
210-300-9044
Facility:
Name:
Fairfax Northern Virginia Hematology Oncology PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexander Spira, Site 305
Phone:
703-280-5390
Facility:
Name:
University of Washington (UW) - Seattle Cancer Care Alliance
Address:
City:
Seattle
Zip:
98109 1023
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elena Gabriela Chiorean, Site 307
Start date:
March 20, 2023
Completion date:
August 30, 2026
Lead sponsor:
Agency:
Mirati Therapeutics Inc.
Agency class:
Industry
Source:
Mirati Therapeutics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737706
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.BMSStudyConnect.com
