Metastatic Cancer Clinical Trial
Official title:
A Phase 1/2 Trial of MRTX849 in Combination With TNO155 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL 2
| Verified date | June 2024 |
| Source | Mirati Therapeutics Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 86 |
| Est. completion date | December 24, 2024 |
| Est. primary completion date | July 29, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois |
| United States | Henry Ford Medical Center - Columbus | Detroit | Michigan |
| United States | University of California Los Angeles - Jonsson Comprehensive Cancer Center | Los Angeles | California |
| United States | Froedtert Hospital | Milwaukee | Wisconsin |
| United States | Memorial Sloan Kettering Cancer Center - New York | New York | New York |
| United States | Perlmutter Cancer Center - 34th Street | New York | New York |
| United States | University of California Irvine Medical Center | Orange | California |
| United States | Siteman Cancer Center - Washington University Medical Campus | Saint Louis | Missouri |
| United States | NEXT Oncology - NEXT San Antonio | San Antonio | Texas |
| United States | Cancer Center of Kansas - Wichita - Heritage Plaza | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Mirati Therapeutics Inc. | Novartis |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Evaluate the pharmacokinetics of MRTX849 and TNO155 | Blood plasma concentration | 20 months | |
| Secondary | Establish maximum tolerated dose | Number of participants with dose limiting toxicity | 12 months | |
| Secondary | Evaluate clinical activity of MRTX849 | Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) | 20 months |
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