Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)

February 7, 2025 updated by: Mirati Therapeutics Inc.

A Phase 1/1b Trial of MRTX849 in Combination With Palbociclib in Patients With Advanced Solid Tumors With KRAS G12C Mutation

This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the pharmacokinetics and preliminary clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and palbociclib is a small molecule inhibitor of CDK 4 and 6.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32827
        • Local Institution - 804
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 803
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 802
      • San Antonio, Texas, United States, 78229
        • Local Institution - 801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
  • Unresectable or metastatic disease.
  • No available treatment with curative intent
  • Adequate organ function

Exclusion Criteria:

  • History of significant toxicity on prior KRAS G12C or CDK4/6 inhibitor therapies
  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter the absorption of study treatment or result in an inability to swallow
  • Other active cancer
  • Cardiac abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.
Drug: MRTX849
KRAS G12C inhibitor
Other Names:
  • adagrasib
  • KRAS G12C
Drug: Palbociclib
CDK 4 and 6 inhibitor
Other Names:
  • IBRANCE
Experimental: Dose Expansion
Expansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib.
Drug: MRTX849
KRAS G12C inhibitor
Other Names:
  • adagrasib
  • KRAS G12C
Drug: Palbociclib
CDK 4 and 6 inhibitor
Other Names:
  • IBRANCE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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: 24 months
Number of participants with treatment emergent adverse events
24 months
Evaluate Pharmacokinetics of the combination regimen
Time Frame: 24 months
Plasma concentration
24 months
Establish Maximum Tolerated Dose
Time Frame: 24 months
Number of patients with dose limiting toxicity
24 months
Evaluate preliminary clinical activity of the combination regimen
Time Frame: 24 months
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirati Therapeutics Inc.

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA239-0018 (Other Identifier: Bristol-Myers Squibb Protocol ID)
  • 849-016 (Other Identifier: Mirati Therapeutics Protocol ID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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