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Trial Title:
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)
NCT ID:
NCT05840510
Condition:
Solid Tumor, Adult
NSCLC
Advanced Cancer
Metastatic Cancer
Malignant Neoplastic Disease
Conditions: Official terms:
Neoplasms
Sirolimus
Adagrasib
Conditions: Keywords:
KRAS
NSCLC
Adagrasib
KRAS G12C
mTOR
nab-sirolimus
Fyarro
ABI-009
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adagrasib
Description:
KRAS G12C inhibitor
Arm group label:
Dose Escalation and Clinical Efficacy
Other name:
MRTX849
Other name:
Krazati
Intervention type:
Drug
Intervention name:
nab-Sirolimus
Description:
mTOR inhibitor
Arm group label:
Dose Escalation and Clinical Efficacy
Other name:
ABI -009
Other name:
Fyarro
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44121
Country:
United States
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030-4000
Country:
United States
Start date:
August 7, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Mirati Therapeutics Inc.
Agency class:
Industry
Collaborator:
Agency:
Aadi Bioscience, Inc.
Agency class:
Industry
Source:
Mirati Therapeutics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05840510
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.BMSStudyConnect.com
