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Phase 1/2 Study in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL 2

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ClinicalTrials.gov Identifier: NCT04330664
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE March 30, 2020
First Posted Date  ICMJE April 1, 2020
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE April 22, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Characterize the safety of MRTX849 and TNO155 in patients having advanced solid tumor malignancies with KRAS G12C mutation. [ Time Frame: 20 months ]
    Number of participants with treatment related adverse events
  • Evaluate the pharmacokinetics of MRTX849 and TNO155 [ Time Frame: 20 months ]
    Blood plasma concentration
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • Characterize the safety of MRTX849 and TNO155 in patients having advanced solid tumor malignancies with KRAC G12C mutation. [ Time Frame: 20 months ]
    Number of participants with treatment related adverse events
  • Evaluate the pharmacokinetics of MRTX849 and TNO155 [ Time Frame: 20 months ]
    Blood plasma concentration
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • Establish maximum tolerated dose [ Time Frame: 12 months ]
    Number of participants with dose limiting toxicity
  • Evaluate clinical activity of MRTX849 [ Time Frame: 20 months ]
    Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1/2 Study in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL 2
Official Title  ICMJE A Phase 1/2 Trial of MRTX849 in Combination With TNO155 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL 2
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 G12C mutation.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Metastatic Cancer
  • Malignant Neoplastic Disease
Intervention  ICMJE
  • Drug: MRTX849
    KRAS G12C Inhibitor
  • Drug: TNO155
    SHP2 Inhibitor
Study Arms  ICMJE
  • Experimental: Phase 1 Dose Exploration
    Dose escalation of TNO155 to determine maximum tolerated dose of TNO155 in combination with MRTX849
    Interventions:
    • Drug: MRTX849
    • Drug: TNO155
  • Experimental: 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
    Interventions:
    • Drug: MRTX849
    • Drug: TNO155
  • Experimental: 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
    Interventions:
    • Drug: MRTX849
    • Drug: TNO155
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2020)
148
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530 miratistudylocator@emergingmed.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04330664
Other Study ID Numbers  ICMJE 849-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mirati Therapeutics Inc.
Study Sponsor  ICMJE Mirati Therapeutics Inc.
Collaborators  ICMJE Novartis
Investigators  ICMJE
Study Director: Andrew Chi, MD Mirati Therapeutics Inc.
PRS Account Mirati Therapeutics Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP