Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCLA
Dates
study started
estimated completion

Description

Summary

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 G12C mutation.

Official Title

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

Details

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.

Keywords

Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease KRAS G12C Non-small cell lung cancer Colorectal Cancer Colon Cancer Pancreatic Cancer NSCLC SHP2 Advanced Solid Tumors Neoplasm Metastasis Neoplasms MRTX849 TNO155

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States
  • UC Irvine Health accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
ID
NCT04330664
Phase
Phase 1/2
Study Type
Interventional
Last Updated