Colon Cancer Clinical Trial
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
Summary
This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.
Full Description
This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 1b must be either Non-Small Cell Lung Cancer or Colorectal Cancer)
Unresectable or metastatic disease
No available treatment with curative intent
Adequate organ function
Exclusion Criteria:
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
Other active cancer
Cardiac abnormalities
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There are 4 Locations for this study
Saint Louis Missouri, 63110, United States
Cleveland Ohio, 44195, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
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