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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) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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)

A Phase 1/2 Trial of Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation

NCT05840510•Mirati Therapeutics Inc.

View on ClinicalTrials.gov

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.

Detailed 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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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
•History of interstitial lung disease or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease or pneumonitis
•Cardiac abnormalities

Locations (3)

Local Institution - 019-104

Cleveland, Ohio, United States

Local Institution - 019-101

Nashville, Tennessee, United States

Local Institution - 019-102

Houston, Texas, United States

Key Dates

Start Date

August 7, 2023

Primary Completion Date

December 27, 2024

Completion Date

December 27, 2024

Last Updated

April 25, 2025

Enrollment

ACTUAL participants

Conditions

Solid Tumor, AdultNSCLCAdvanced CancerMetastatic CancerMalignant Neoplastic Disease

Interventions

Adagrasib

DRUG

nab-Sirolimus

DRUG

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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RECRUITINGPHASE3

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NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGNA

Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

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Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers