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A Phase 1/2 of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

Program Status

Recruiting

Phase

PHASE1 PHASE2

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

MRTX1133

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

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.”

Location Location Status
United States
Mayo Clinic Hospital
Phoenix, Arizona 85054
RECRUITING
Yale Cancer Center
New Haven, Connecticut 06520 8028
RECRUITING
Florida Cancer Specialists & Research Institute (FCS) - Villages East
Lady Lake, Florida 32159 8987
RECRUITING
John Hopkins Medicine - Hematology/oncology
Baltimore, Maryland 21231
RECRUITING
Massachusetts General Hospital (MGH)
Boston, Massachusetts 02114 3117
RECRUITING
Dana Farber Cancer Institute
Boston, Massachusetts 02215
RECRUITING
South Texas Accelerated Research Therapeutics (START) - Midwest
Grand Rapids, Michigan 49546
RECRUITING
Memorial Sloan-Kettering Cancer Center
New York, New York 10065 6800
RECRUITING
SCRI Oncology Partners
Nashville, Tennessee 37203
RECRUITING
UT MD Anderson Cancer Center
Houston, Texas 77030
RECRUITING
The START Center for Cancer Care
San Antonio, Texas 78229 3307
RECRUITING
Next Oncology - Oncology
San Antonio, Texas 78229
RECRUITING
Fairfax Northern Virginia Hematology Oncology PC
Fairfax, Virginia 22031
RECRUITING
University of Washington (UW) - Seattle Cancer Care Alliance
Seattle, Washington 98109 1023
RECRUITING

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286 Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

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.

NCT ID

NCT05737706

Date Trial Added

2023-02-21

Updated Date

2024-06-21