Active, Not Recruiting
Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation - CA246-0005
Updated: 8 leden, 2025 | ClinicalTrials.gov
Fáze
Pohlaví
Věková skupina
Active, Not Recruiting
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.
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