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

a study on Cancer, General Malignant Neoplasm Solid Tumor Neoplasms

Eligibility: for people ages 18 years and up (full criteria)
Location: at Orange, California and other locations
Dates: study started January 2019
completion around January 2026

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 Irvine Medical Center accepting new patients
Orange California 92868 United States
Hoag Memorial Hospital Presbyterian - Newport Beach accepting new patients
Newport Beach California 92663 United States
TRIO - Cancer and Blood Specialty Clinic accepting new patients
Los Alamitos California 90720 United States
Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton accepting new patients
Fullerton California 92835 United States
Local Institution - 001-840-B not yet accepting patients
Bellflower California 90706 United States
Local Institution - 001-840-C not yet accepting patients
Harbor City California 90710 United States

Details

Status: accepting new patients
Start Date: January 2019
Completion Date: January 2026 (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: September 2024

I’m interested in this study!