Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)

Last updated: April 22, 2025
Sponsor: Mirati Therapeutics Inc.
Overall Status: Terminated

Phase

1

Condition

Non-small Cell Lung Cancer

Metastatic Cancer

Neoplasm Metastasis

Treatment

Adagrasib

nab-Sirolimus

Clinical Study ID

NCT05840510
CA239-0011
CA239-0011
849-019
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the safety, MTD and/or RP2D, PK, and clinical activity of the combination of adagrasib with nab-sirolimus in patients with advanced solid tumors/NSCLC with a KRAS G12C mutation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of solid tumor malignancy (Phase 1) or NSCLC (Phase 2) with KRAS G12C mutation

  • Unresectable or metastatic disease

  • No available treatment with curative intent

  • Adequate organ function

  • Measurable disease per RECIST 1.1.

Exclusion

Exclusion Criteria:

  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, orother gastrointestinal conditions likely to alter absorption of study treatment orresult in inability to swallow

  • History of interstitial lung disease or radiation pneumonitis requiring steroidtreatment, or any evidence of clinically active interstitial lung disease orpneumonitis

  • Cardiac abnormalities

Study Design

Total Participants: 6
Treatment Group(s): 2
Primary Treatment: Adagrasib
Phase: 1
Study Start date:
August 07, 2023
Estimated Completion Date:
December 27, 2024

Study Description

This study will evaluate the safety and tolerability and clinical activity of adagrasib in combination with nab-sirolimus in patients with advanced solid tumors harboring a KRAS G12C mutation.

The Phase 1 portion will enroll advanced solid tumors to establish the maximum tolerated dose (MTD) and/or to identify recommended Phase 2 combinatorial doses. The Phase 2 portion will enroll patients with NSCLC to further evaluate the safety/tolerability and clinical activity.

Adagrasib is an orally available small molecule inhibitor of KRAS G12C. nab-Sirolimus is a nanoparticle albumin-bound (nab) form of sirolimus, and sirolimus is an inhibitor of mechanistic target of rapamycin kinase (mTOR, previously known as mammalian target of rapamycin).

Connect with a study center

  • Local Institution - 019-104

    Cleveland, Ohio 44121
    United States

    Site Not Available

  • Research Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44121
    United States

    Site Not Available

  • Local Institution - 019-101

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Local Institution - 019-102

    Houston, Texas 77030-4000
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030-4000
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030-4000
    United States

    Site Not Available

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