This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors that have a KRAS G12C mutation.
Name: MRTX849
Name: TNO155
Description: Number of participants with treatment related adverse events
Measure: Characterize the safety of MRTX849 and TNO155 in patients having advanced solid tumor malignancies with KRAS G12C mutation. Time: 20 monthsDescription: Blood plasma concentration
Measure: Evaluate the pharmacokinetics of MRTX849 and TNO155 Time: 20 monthsDescription: Number of participants with dose limiting toxicity
Measure: Establish maximum tolerated dose Time: 12 monthsDescription: Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Measure: Evaluate clinical activity of MRTX849 Time: 20 monthsAllocation: Non-Randomized
Sequential Assignment
There is one SNP
A Phase 1/2 Trial of MRTX849 in Combination With TNO155 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL 2. Phase 1/2 Study in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL 2 This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors that have a KRAS G12C mutation. --- G12C ---
A Phase 1/2 Trial of MRTX849 in Combination With TNO155 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL 2. Phase 1/2 Study in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL 2 This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors that have a KRAS G12C mutation. --- G12C --- --- G12C ---
A Phase 1/2 Trial of MRTX849 in Combination With TNO155 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL 2. Phase 1/2 Study in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL 2 This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors that have a KRAS G12C mutation. --- G12C --- --- G12C --- --- G12C ---
Characterize the safety of MRTX849 and TNO155 in patients having advanced solid tumor malignancies with KRAS G12C mutation.. Number of participants with treatment related adverse events. --- G12C ---
Inclusion Criteria: - Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 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 Inclusion Criteria: - Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 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 Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease Neoplasm Metastasis Neoplasms This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors with a KRAS G12C mutation. --- G12C ---
Inclusion Criteria: - Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 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 Inclusion Criteria: - Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 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 Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease Neoplasm Metastasis Neoplasms This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors with a KRAS G12C mutation. --- G12C --- --- G12C ---
Inclusion Criteria: - Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 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 Inclusion Criteria: - Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 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 Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease Neoplasm Metastasis Neoplasms This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors with a KRAS G12C mutation. --- G12C --- --- G12C --- --- G12C ---
MRTX849 is an orally available small molecule inhibitor of KRAS G12C and TNO155 is a selective, orally bioavailable allosteric inhibitor of wild-type SHP2. --- G12C ---