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Rechercher Study Connect

Active, Not Recruiting

Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation - CA246-0005

Mis à jour: 8 janvier, 2025   |   ClinicalTrials.gov

Résumé imprimable

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Détails de l’essai

  • Phase 1/Phase 2

    Phase

  • Sexe(s)

  • 18+

    Tranche d’âge

  • Active, Not Recruiting

Options de traitement

Bras de l’étude
INTERVENTION ASSIGNÉE
Experimental: Phase 1/1B
Drug: MRTX1133
Experimental: Phase 2
Drug: MRTX1133

Principaux critères d’éligibilité

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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Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici
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