A Phase 1/2 Trial of MRTX849 in Combination with TNO155 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

Phase

1/2

Condition

Colon Cancer

Metastatic Cancer

Solid Tumors

Treatment

N/A

Clinical Study ID

TX245183

Ages 18-99
All Genders

Study Summary

Characterize the safety and tolerability, and evaluate Pharmacokinetics of MRTX849 in combination with TNO155 in patients with advanced solid tumor malignancies with KRAS G12C mutation.

MRTX849 is an orally available small molecute inhibitor of KRASG12C.
TNO155 is a selective, orally bioavailable allosteric inhibitor of wild type SHP2.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 must be either NSCLC or CRC)
Unresectable or metastatic disease
No available treatment with curative intent
Adequate organ function

Exclusion

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 Design

Study Description

Phase 1/1b to establish the maximum tolerated dose of the combination of study drugs in patients with advanced solid tumor malignancies with a KRAS G12C mutation.
Phase 2 to evaluate clinical activity of the combination of study drugs in selected solid tumor malignancies with KRAS G12C mutation.

Connect with a study center

University of California Irvine Medical Center
Orange, California 92868
United States
Active - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Active - Recruiting
Washington University St. Louis
St. Louis, Missouri 63110
United States
Active - Recruiting
NYU Langone
New York, New York 10016
United States
Active - Recruiting
Next Oncology
San Antonio, Texas 78229
United States
Active - Recruiting

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