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The decision was made to terminate this study to further enrollment, as of 08 March 2022. The decision was made primarily due to a change in development strategy.
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental | Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination |
|
| Dose expansion | Experimental | Expansion cohorts in NSCLC and CRC patients to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with BI 1701963 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRTX849 | Drug | KRAS G12C inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation | Number of participants with treatment related adverse events | 20 months |
| Evaluate Pharmacokinetics of the combination regimen | Blood plasma concentration | 20 months |
| Establish Maximum Tolerated Dose | Number of patients with dose limiting toxicity | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate preliminary clinical activity of the combination regimen | Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) | 20 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Chao, MD | Mirati Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States | ||
| The Cleveland Clinic Foundation |
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| BI 1701963 | Drug | SOS1 Inhibitor |
|
|
| Cleveland |
| Ohio |
| 44195 |
| United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Next Oncology | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D003110 | Colonic Neoplasms |
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000718190 | adagrasib |
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