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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.

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Malignant Neoplasm of Colon Malignant Neoplasm of Lung Malignant Neoplastic Disease Drug: MRTX849 Drug: BI 1701963 Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
Actual Study Start Date : August 12, 2021
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose escalation
Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination
Drug: MRTX849
KRAS G12C inhibitor
Other Names:
  • KRAS G12C inhibitor
  • adagrasib

Drug: BI 1701963
SOS1 Inhibitor
Other Name: SOS1 Inhibitor

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
Drug: MRTX849
KRAS G12C inhibitor
Other Names:
  • KRAS G12C inhibitor
  • adagrasib

Drug: BI 1701963
SOS1 Inhibitor
Other Name: SOS1 Inhibitor




Primary Outcome Measures :
  1. 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

  2. Evaluate Pharmacokinetics of the combination regimen [ Time Frame: 20 months ]
    Blood plasma concentration

  3. Establish Maximum Tolerated Dose [ Time Frame: 12 months ]
    Number of patients with dose limiting toxicity


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04975256


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Next Oncology
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Mirati Therapeutics Inc.
Boehringer Ingelheim
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04975256    
Other Study ID Numbers: 849-014
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mirati Therapeutics Inc.:
KRAS G12C
SOS1 Inhibitor
NSCLC
CRC
Non Small Cell Lung Cancer
Colon Cancer
Advanced Solid Tumor
Metastatic Cancer
Pancreatic Cancer
adagrasib
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Lung Neoplasms
Colonic Neoplasms
Neoplastic Processes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Adagrasib
Antineoplastic Agents