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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05178888
• Other study ID #: 849-016
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 1, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: October 2022
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: March 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• MRTX849
KRAS G12C inhibitor
• Palbociclib
CDK 4 and 6 inhibitor

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon	Nashville	Tennessee
United States	Florida Cancer Specialists	Orlando	Florida
United States	Next Oncology	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evaluate Pharmacokinetics of the combination regimen	Plasma concentration	24 months
Primary	Establish Maximum Tolerated Dose	Number of patients with dose limiting toxicity	24 months
Primary	Evaluate preliminary clinical activity of the combination regimen	Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)	24 months