Adagrasib in Combination With TNO155 in Patients With Cancer (KRYSTAL 2)
NCT ID: NCT04330664
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
86 participants
INTERVENTIONAL
2020-04-07
2025-02-24
Brief Summary
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Detailed Description
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This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1 Dose Exploration
Dose escalation of TNO155 to determine maximum tolerated dose of TNO155 in combination with MRTX849
MRTX849
KRAS G12C Inhibitor
TNO155
SHP2 Inhibitor
Phase 1b Expansion
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
MRTX849
KRAS G12C Inhibitor
TNO155
SHP2 Inhibitor
Phase 2
Separate cohorts of patients stratified by histological diagnosis for evaluation of clinical activity to evaluate clinical activity of MRTX849 and TNO155 in combination
MRTX849
KRAS G12C Inhibitor
TNO155
SHP2 Inhibitor
Interventions
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MRTX849
KRAS G12C Inhibitor
TNO155
SHP2 Inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function
Exclusion Criteria
* Other active cancer
* Cardiac abnormalities
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 002-805
Los Angeles, California, United States
Local Institution - 002-803
Orange, California, United States
Local Institution - 002-828
Chicago, Illinois, United States
Local Institution - 002-942
Wichita, Kansas, United States
Local Institution - 002-804
Boston, Massachusetts, United States
Local Institution - 002-808
Boston, Massachusetts, United States
Local Institution - 002-811
Novi, Michigan, United States
Local Institution - 002-809 D
City of Saint Peters, Missouri, United States
Local Institution - 002-809 B
Creve Coeur, Missouri, United States
Local Institution - 002-809 A
St Louis, Missouri, United States
Local Institution - 002-809 C
St Louis, Missouri, United States
Local Institution - 002-809
St Louis, Missouri, United States
Local Institution - 002-809 E
St Louis, Missouri, United States
Local Institution - 002-813
New York, New York, United States
Local Institution - 002-806
New York, New York, United States
Local Institution - 002-801
San Antonio, Texas, United States
Local Institution - 002-810
Milwaukee, Wisconsin, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA239-0017
Identifier Type: OTHER
Identifier Source: secondary_id
849-002
Identifier Type: OTHER
Identifier Source: secondary_id
CA239-0017
Identifier Type: -
Identifier Source: org_study_id
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