Program Status
Active, not recruitingPhase
Phase 1Prior Immunotherapy Allowed
YesCRC-directed Trial
YesDrugs
MRTX1133Tags
MSI-H/ MMRd, MSS/ MMRpComments
Trial with an oral, novel KRASG12D inhibitor. Expansion cohorts in pancreatic, colorectal, lung and other KRASG12D tumor types. Only for patients with unresectable or metastatic disease.
“MRTX1133 is a highly potent investigational inhibitor of the KRASG12D driver mutation and demonstrated selective and reversible inhibition of KRASG12D in both its active and inactive states. In addition, MRTX1133 administration resulted in marked tumor response in preclinical KRASG12D mutated pancreatic cancer models as well as lung and colorectal cancer models. MRTX1133 has demonstrated favorable properties including a low risk for off-target activity and drug interactions and a predicted human half-life of greater than 50 hours.”
Helpful Links
https://pubs.acs.org/doi/full/10.1021/acsomega.3c00329Location | Location Status |
---|---|
United States | |
Local Institution - 311 Phoenix, Arizona 85054 |
Active, not recruiting |
Local Institution - 309 New Haven, Connecticut 06520 8028 |
Active, not recruiting |
Local Institution - 301 Lady Lake, Florida 32159 8987 |
Active, not recruiting |
Local Institution - 306 Baltimore, Maryland 21231 |
Active, not recruiting |
Local Institution - 308 Boston, Massachusetts 02114 3117 |
Active, not recruiting |
Local Institution - 310 Boston, Massachusetts 02215 |
Active, not recruiting |
Local Institution - 314 Grand Rapids, Michigan 49546 |
Active, not recruiting |
Local Institution - 312 New York, New York 10065 6800 |
Active, not recruiting |
Local Institution - 303 Nashville, Tennessee 37203 |
Active, not recruiting |
Local Institution - 302 Houston, Texas 77030 |
Active, not recruiting |
Local Institution - 304 San Antonio, Texas 78229 3307 |
Active, not recruiting |
Local Institution - 313 San Antonio, Texas 78229 |
Active, not recruiting |
Local Institution - 305 Fairfax, Virginia 22031 |
Active, not recruiting |
Local Institution - 307 Seattle, Washington 98109 1023 |
Active, not recruiting |
Inclusion 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
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.