Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation
About this trial
This is an interventional treatment trial for Advanced Solid Tumors
Eligibility Criteria
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 performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Exclusion Criteria:
- Primary brain tumor.
- Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
- Myocardial infarction within 6 months of study day 1.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Sites / Locations
- Arizona Oncology Associates Professional CorporationRecruiting
- City of Hope National Medical CenterRecruiting
- University of California San Diego Moores Cancer Center
- Loma Linda University Cancer CenterRecruiting
- University of Southern California, Norris Comprehensive Cancer CenterRecruiting
- University of California Davis Medical CenterRecruiting
- University of California at SFRecruiting
- University of California Los AngelesRecruiting
- Rocky Mountain Cancer Centers Denver MidtownRecruiting
- Sarah Cannon Research Institute at HealthONERecruiting
- Yale Cancer CenterRecruiting
- Norwalk HospitalRecruiting
- Memorial Cancer InstituteRecruiting
- Moffitt Cancer CenterRecruiting
- Emory UniversityRecruiting
- Northwestern UniversityRecruiting
- University of Chicago Medical CenterRecruiting
- Indiana UniversityRecruiting
- University of Iowa Hospitals and ClinicsRecruiting
- Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterRecruiting
- University of MichiganRecruiting
- Henry Ford Health SystemRecruiting
- Washington UniversityRecruiting
- Montefiore Medical Center
- Roswell Park Cancer InstituteRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- Columbia University Medical CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Levine Cancer InstituteRecruiting
- Duke University Medical CenterRecruiting
- University of Cincinnati Medical CenterRecruiting
- Cleveland Clinic
- Providence Portland Medical CenterRecruiting
- Oregon Health and Science UniversityRecruiting
- Thomas Jefferson UniversityRecruiting
- Fox Chase Cancer Center
- University of PennsylvaniaRecruiting
- University of Pittsburgh Medical Center Cancer PavillionRecruiting
- Gibbs Cancer Center and Research Institute - SpartanburgRecruiting
- Avera Cancer Institute
- Henry Joyce Cancer CenterRecruiting
- Texas Oncology - Austin MidtownRecruiting
- Mary Crowley Cancer ResearchRecruiting
- University of Texas Southwestern Medical CenterRecruiting
- Oncology ConsultantsRecruiting
- University of Texas MD Anderson Cancer CenterRecruiting
- United States Oncology Regulatory Affairs Corporate OfficeRecruiting
- US Oncology Research Investigational Products CenterRecruiting
- Texas Oncology-TylerRecruiting
- Huntsman Cancer InstituteRecruiting
- University of VirginiaRecruiting
- Virginia Cancer Specialists, PCRecruiting
- Fred Hutchinson Cancer CenterRecruiting
- Northwest Medical Specialties, PLLCRecruiting
- Northwest Cancer Specialists - VancouverRecruiting
- Nepean Cancer CentreRecruiting
- GenesisCare -North Shore OncologyRecruiting
- Icon Cancer Care South BrisbaneRecruiting
- The Queen Elizabeth HospitalRecruiting
- St John of God HealthcareRecruiting
- Medizinische Universitaet GrazRecruiting
- Universitaetsklinikum SalzburgRecruiting
- Universite Catholique de Louvain Cliniques Universitaires Saint LucRecruiting
- Universitair Ziekenhuis AntwerpenRecruiting
- CHU de Quebec Hopital de l Enfant JesusRecruiting
- Charite Universitaetsmedizin Berlin, Campus VirchowRecruiting
- Universitaetsklinikum Carl Gustav CarusRecruiting
- Universitaetsklinikum EssenRecruiting
- Universitatsklinikum KolnRecruiting
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting
- Azienda Ospedaliera Universitaria Pisana Ospedale Santa ChiaraRecruiting
- Centro Ricerche ClinicheRecruiting
- Aichi Cancer CenterRecruiting
- National Cancer Center Hospital EastRecruiting
- The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchRecruiting
- Seoul National University HospitalRecruiting
- The Catholic University of Korea Seoul St Marys HospitalRecruiting
- Asan Medical CenterRecruiting
- Universitair Medisch Centrum UtrechtRecruiting
- Hospital Universitari Vall d HebronRecruiting
- Hospital Clinic i Provincial de BarcelonaRecruiting
- Institut Catala d Oncologia Hospitalet Hospital Duran i ReynalsRecruiting
- Hospital Universitario Puerta de Hierro MajadahondaRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- National Cheng Kung University HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Linkou Chang Gung Memorial Hospital of Chang Gung Medical FoundationRecruiting
- Sarah Cannon Research Institute UKRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Sotorasib + trametinib + panitumumab
Sotorasib + RMC-4630
Sotorasib + afatinib
Sotorasib + panitumumab +/- FOLFIRI
Sotorasib + atezolizumab
Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab
Sotorasib Monotherapy
Sotorasib + palbociclib
Sotorasib + pembrolizumab
Sotorasib + MVASI® (bevacizumab-awwb)+ FOLFIRI or FOLFOX
Sotorasib + TNO155
Sotorasib + BI 1701963
Sotorasib + AMG 404
Sotorasib + everolimus
Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.
Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
Experimental: Sotorasib + panitumumab +/- FOLFIRI Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
Experimental: Sotorasib only Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.
Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.
Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant non small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant non small cell lung cancer.
Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ FOLFIRI or FOLFOX Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.
Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.
Experimental: Sotorasib + AMG 404 Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors
Experimental: Sotorasib + everolimus Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.