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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330664
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease Drug: MRTX849 Drug: TNO155 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Trial of MRTX849 in Combination With TNO155 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
Actual Study Start Date : April 22, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1 Dose Exploration
Dose escalation of TNO155 to determine maximum tolerated dose of TNO155 in combination with MRTX849
Drug: MRTX849
KRAS G12C Inhibitor

Drug: TNO155
SHP2 Inhibitor

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
Drug: MRTX849
KRAS G12C Inhibitor

Drug: TNO155
SHP2 Inhibitor

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
Drug: MRTX849
KRAS G12C Inhibitor

Drug: TNO155
SHP2 Inhibitor




Primary Outcome Measures :
  1. 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

  2. Evaluate the pharmacokinetics of MRTX849 and TNO155 [ Time Frame: 20 months ]
    Blood plasma concentration


Secondary Outcome Measures :
  1. Establish maximum tolerated dose [ Time Frame: 12 months ]
    Number of participants with dose limiting toxicity

  2. Evaluate clinical activity of MRTX849 [ 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 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

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): NCT04330664


Contacts
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Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530 miratistudylocator@emergingmed.com

Locations
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United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Mirati Therapeutics Inc.
Novartis
Investigators
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Study Director: Andrew Chi, MD Mirati Therapeutics Inc.
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04330664    
Other Study ID Numbers: 849-002
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
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
Non-small cell lung cancer
Colorectal Cancer
Colon Cancer
Metastatic Cancer
Pancreatic Cancer
NSCLC
SHP2
Advanced Solid Tumors
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes