A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Who can participate
Inclusion Criteria:
* Men or women greater than or equal to 18 years old.
* Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.
Exclusion Criteria
* Active brain metastases from non-brain tumors.
* Myocardial infarction within 6 months of study day 1.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Locations
15
Australia (1)
Scientia Clinical Research Ltd
Randwick , New South Wales
Belgium (1)
Institut Jules Bordet
Brussels
Brazil (1)
Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer
Porto Alegre , Rio Grande do Sul
Canada (1)
Tom Baker Cancer Centre
Calgary , Alberta
France (1)
Institut Bergonie
Bordeaux
Germany (1)
Universitatsklinikum Koln
Cologne
Greece (1)
Henry Dunant Hospital Center
Athens
Hungary (1)
Semmelweis Egyetem
Budapest
Japan (1)
Aichi Cancer Center
Nagoya , Aichi-ken
Portugal (1)
Fundacao Champalimaud
Lisbon
Romania (1)
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
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