Colon Cancer Clinical Trial

Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)

Summary

This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.

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Full Description

This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 1b must be either Non-Small Cell Lung Cancer or Colorectal Cancer)
Unresectable or metastatic disease
No available treatment with curative intent
Adequate organ function

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
Other active cancer
Cardiac abnormalities

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

7

Study ID:

NCT04975256

Recruitment Status:

Completed

Sponsor:

Mirati Therapeutics Inc.

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There are 4 Locations for this study

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Washington University School of Medicine
Saint Louis Missouri, 63110, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Next Oncology
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

7

Study ID:

NCT04975256

Recruitment Status:

Completed

Sponsor:


Mirati Therapeutics Inc.

How clear is this clinincal trial information?

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