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Trial record 1 of 1 for:    849-014
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Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04975256
Recruitment Status : Active, not recruiting
First Posted : July 23, 2021
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE July 6, 2021
First Posted Date  ICMJE July 23, 2021
Last Update Posted Date April 6, 2022
Actual Study Start Date  ICMJE August 12, 2021
Estimated Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2021)
  • 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 [ Time Frame: 20 months ]
    Number of participants with treatment related adverse events
  • Evaluate Pharmacokinetics of the combination regimen [ Time Frame: 20 months ]
    Blood plasma concentration
  • Establish Maximum Tolerated Dose [ Time Frame: 12 months ]
    Number of patients with dose limiting toxicity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2021)
Evaluate preliminary clinical activity of the combination regimen [ 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 Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
Official Title  ICMJE A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Metastatic Cancer
  • Malignant Neoplasm of Colon
  • Malignant Neoplasm of Lung
  • Malignant Neoplastic Disease
Intervention  ICMJE
  • Drug: MRTX849
    KRAS G12C inhibitor
    Other Names:
    • KRAS G12C inhibitor
    • adagrasib
  • Drug: BI 1701963
    SOS1 Inhibitor
    Other Name: SOS1 Inhibitor
Study Arms  ICMJE
  • Experimental: Dose escalation
    Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination
    Interventions:
    • Drug: MRTX849
    • Drug: BI 1701963
  • Experimental: Dose expansion
    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
    Interventions:
    • Drug: MRTX849
    • Drug: BI 1701963
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2024
Estimated Primary Completion Date November 30, 2023   (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 1b 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04975256
Other Study ID Numbers  ICMJE 849-014
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
Current Responsible Party Mirati Therapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mirati Therapeutics Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Boehringer Ingelheim
Investigators  ICMJE Not Provided
PRS Account Mirati Therapeutics Inc.
Verification Date April 2022

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