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Program Status Clinical trial’s patient recruitment status
Phase Phase of the clinical trial that is recruiting (I, II, or III)
Immunotherapy-centered Trial A flag to indicate whether the trial is an immunotherapy trial
Prior Immunotherapy Allowed Whether the clinical trial is open to patients who have received prior immunotherapy
CRC-directed Trial A flag to indicate whether the trial is specifically targeting colon cancer, rectal cancer, or colorectal cancer patients
Drugs Therapeutics used in the clinical trial
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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.”
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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:
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
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 Trial ID number from clinicaltrials.gov or other database
Date Trial Added Date on which the clinical trial was added to the clinicaltrials.gov website
Updated Date Date on which the clinical trial was updated on the clinicaltrials.gov website