Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

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 UC Irvine UCSD
Dates
study started
completion around

Description

Summary

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

Official Title

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1

Details

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

Keywords

Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease, KRAS, NSCLC, Colorectal Cancer, Colon Cancer, Pancreatic Cancer, Adagrasib, STK11 mutation, KRAS G12C, Neoplasm Metastasis, Neoplasms, Pembrolizumab, Cetuximab, Afatinib, MRTX849

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
  • Unresectable or metastatic disease
  • Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
  • Adequate organ function

You CAN'T join if...

  • History of intestinal disease or major gastric surgery or inability to swallow oral medications
  • Other active cancer

Locations

  • University of California San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Local Institution - 001-850-E not yet accepting patients
    San Francisco California 94115 United States
  • Valkyrie Clinical Trials accepting new patients
    Los Angeles California 90067 United States
  • Beverly Hills Cancer Center accepting new patients
    Beverly Hills California 90211 United States
  • Hoag Memorial Hospital Presbyterian - Newport Beach accepting new patients
    Newport Beach California 92663 United States
  • California Cancer Associates for Research and Excellence (cCARE) - San Diego 4S Ranch accepting new patients
    San Diego California 92111 United States
  • Local Institution - 001-850-H not yet accepting patients
    San Francisco California 94080 United States
  • Southern California Permanente Medical Group - Los Angeles Medical Center accepting new patients
    Los Angeles California 90027 United States
  • Local Institution - 001-840-A not yet accepting patients
    San Diego California 92120 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT03785249
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 822 study participants
Last Updated