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COMPLETEDPhase 1NCT04330664

Adagrasib in Combination With TNO155 in Patients With Cancer (KRYSTAL 2)

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors that have a KRAS G...

Lead sponsor: Mirati Therapeutics Inc.•17 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Mirati Therapeutics Inc.

Collaborators

Novartis

This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and TNO155 is a selective, orally bioavailable allosteric inhibitor of wild-type SHP2. This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 4, 2025Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment86

Start dateApr 2020

Last updatedApr 4, 2025

Condition

Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease

Locations shown

Local Institution - 002-805

Los Angeles, California

Local Institution - 002-803

Orange, California

Local Institution - 002-828

Chicago, Illinois

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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