Status:
COMPLETED
Adagrasib in Combination With TNO155 in Patients With Cancer (KRYSTAL 2)
Lead Sponsor:
Mirati Therapeutics Inc.
Collaborating Sponsors:
Novartis
Conditions:
Advanced Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 G...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2025
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04330664
Start Date
April 7 2020
End Date
February 24 2025
Last Update
April 4 2025
Active Locations (17)
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1
Local Institution - 002-805
Los Angeles, California, United States, 90095
2
Local Institution - 002-803
Orange, California, United States, 92868
3
Local Institution - 002-828
Chicago, Illinois, United States, 60611
4
Local Institution - 002-942
Wichita, Kansas, United States, 67214