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| ID | Type | Description | Link |
|---|---|---|---|
| CA239-0017 | Other Identifier | Bristol-Myers Squibb Protocol ID | |
| 849-002 | Other Identifier | Mirati Therapeutics Protocol ID |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and TNO155 is a selective, orally bioavailable allosteric inhibitor of wild-type SHP2.
This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Exploration | Experimental | Dose escalation of TNO155 to determine maximum tolerated dose of TNO155 in combination with MRTX849 |
|
| Phase 1b Expansion | Experimental | Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with TNO155 to recommend Phase 2 regimens |
|
| Phase 2 | Experimental | Separate cohorts of patients stratified by histological diagnosis for evaluation of clinical activity to evaluate clinical activity of MRTX849 and TNO155 in combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRTX849 | Drug | KRAS G12C Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 20 months |
| Evaluate the pharmacokinetics of MRTX849 and TNO155 | Blood plasma concentration | 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Establish maximum tolerated dose | Number of participants with dose limiting toxicity | 12 months |
| Evaluate clinical activity of MRTX849 | Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 002-805 | Los Angeles | California | 90095 | United States | ||
| Local Institution - 002-803 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| TNO155 | Drug | SHP2 Inhibitor |
|
| 20 months |
| Orange |
| California |
| 92868 |
| United States |
| Local Institution - 002-828 | Chicago | Illinois | 60611 | United States |
| Local Institution - 002-942 | Wichita | Kansas | 67214 | United States |
| Local Institution - 002-804 | Boston | Massachusetts | 02114 | United States |
| Local Institution - 002-808 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 002-811 | Novi | Michigan | 48377 | United States |
| Local Institution - 002-809 D | City of Saint Peters | Missouri | 63376 | United States |
| Local Institution - 002-809 B | Creve Coeur | Missouri | 63141 | United States |
| Local Institution - 002-809 A | St Louis | Missouri | 63110 | United States |
| Local Institution - 002-809 C | St Louis | Missouri | 63129 | United States |
| Local Institution - 002-809 | St Louis | Missouri | 63130 | United States |
| Local Institution - 002-809 E | St Louis | Missouri | 63136 | United States |
| Local Institution - 002-813 | New York | New York | 10016 | United States |
| Local Institution - 002-806 | New York | New York | 10065 | United States |
| Local Institution - 002-801 | San Antonio | Texas | 78229 | United States |
| Local Institution - 002-810 | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000718190 | adagrasib |
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