Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)
A Phase 1/1b Trial of MRTX849 in Combination With Palbociclib in Patients With Advanced Solid Tumors With KRAS G12C Mutation
2 other identifiers
interventional
11
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2022
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
January 5, 2022
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedFebruary 11, 2025
February 1, 2025
1.4 years
December 1, 2021
February 7, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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.
Number of participants with treatment emergent adverse events
24 months
Evaluate Pharmacokinetics of the combination regimen
Plasma concentration
24 months
Establish Maximum Tolerated Dose
Number of patients with dose limiting toxicity
24 months
Evaluate preliminary clinical activity of the combination regimen
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
24 months
Study Arms (2)
Dose Escalation
EXPERIMENTALDose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.
Dose Expansion
EXPERIMENTALExpansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Local Institution - 804
Orlando, Florida, 32827, United States
Local Institution - 803
Nashville, Tennessee, 37203, United States
Local Institution - 802
Houston, Texas, 77030, United States
Local Institution - 801
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 1, 2021
First Posted
January 5, 2022
Study Start
January 20, 2022
Primary Completion
June 15, 2023
Study Completion
December 30, 2024
Last Updated
February 11, 2025
Record last verified: 2025-02