This study is in progress, not accepting new patients

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

a study on Cancer, General Metastatic Cancer Malignant Neoplasm Solid Tumor Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

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.

This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.

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, Adagrasib, 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

  • University of California Irvine Medical Center
    Orange California 92868 United States
  • University of California Los Angeles - Jonsson Comprehensive Cancer Center
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT04330664
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 86 people participating
Last Updated