Treatment for advanced cancer with a KRAS G12C mutation
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1
This study is testing a new drug called MRTX849 to see if it can help people with advanced cancer that has a specific KRAS G12C mutation feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 822 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mirati Therapeutics Inc. Industry-sponsored |
| Locations | 228 sites (Birmingham, Alabama and 227 other locations) |
| Trial ID | NCT03785249 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of MRTX849 (adagrasib), a small molecule inhibitor, in patients with advanced solid tumors harboring a KRAS G12C mutation. It focuses on assessing drug tolerability, pharmacokinetics, and clinical activity in this specific patient population. Participants will receive MRTX849, with potential combinations including Pembrolizumab, Cetuximab, and Afatinib, depending on their specific cancer type and treatment history.
Who should consider this trial
Good fit: Ideal candidates include patients with unresectable or metastatic solid tumors confirmed to have a KRAS G12C mutation.
Not a fit: Patients with other active cancers or those unable to take oral medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a targeted therapy option for patients with KRAS G12C mutated cancers, potentially improving outcomes.
How similar studies have performed: Previous studies targeting KRAS mutations have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * History of intestinal disease or major gastric surgery or inability to swallow oral medications * Other active cancer
Where this trial is running
Birmingham, Alabama and 227 other locations
- ONeal Comprehensive Cancer Center at the University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Alaska Oncology and Hematology — Anchorage, Alaska, United States (Recruiting)
- Mayo Clinic Arizona - Phoenix Campus — Phoenix, Arizona, United States (Recruiting)
- Local Institution - 001-807 — Scottsdale, Arizona, United States (Withdrawn)
- Local Institution - 001-873-A — Tucson, Arizona, United States (Not_yet_recruiting)
- USOR - Arizona Oncology - Tucson - Rudasill — Tucson, Arizona, United States (Recruiting)
- Local Institution - 001-840-B — Bellflower, California, United States (Not_yet_recruiting)
- Beverly Hills Cancer Center — Beverly Hills, California, United States (Recruiting)
- City of Hope - Duarte (Main Campus) — Duarte, California, United States (Recruiting)
- Local Institution - 001-850-K — Dublin, California, United States (Not_yet_recruiting)
- Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton — Fullerton, California, United States (Recruiting)
- Local Institution - 001-840-C — Harbor City, California, United States (Not_yet_recruiting)
- University of California San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
- TRIO - Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (Recruiting)
- Southern California Permanente Medical Group - Los Angeles Medical Center — Los Angeles, California, United States (Recruiting)
- Valkyrie Clinical Trials — Los Angeles, California, United States (Recruiting)
- Hoag Memorial Hospital Presbyterian - Newport Beach — Newport Beach, California, United States (Recruiting)
- Local Institution - 001-850-B — Oakland, California, United States (Not_yet_recruiting)
- University of California Irvine Medical Center — Orange, California, United States (Recruiting)
- Local Institution - 001-850-C — Roseville, California, United States (Not_yet_recruiting)
- Local Institution - 001-850-J — Sacramento, California, United States (Not_yet_recruiting)
- Local Institution - 001-850-D — Sacramento, California, United States (Not_yet_recruiting)
- California Cancer Associates for Research and Excellence (cCARE) - San Diego 4S Ranch — San Diego, California, United States (Recruiting)
- Local Institution - 001-840-A — San Diego, California, United States (Not_yet_recruiting)
- Local Institution - 001-850-H — San Francisco, California, United States (Not_yet_recruiting)
- Local Institution - 001-850-E — San Francisco, California, United States (Not_yet_recruiting)
- Local Institution - 001-850-F — San Jose, California, United States (Not_yet_recruiting)
- Local Institution - 001-850-A — San Leandro, California, United States (Not_yet_recruiting)
- Ridley - Tree Cancer Center - Santa Barbara — Santa Barbara, California, United States (Recruiting)
- Local Institution - 001-850-I — Santa Clara, California, United States (Not_yet_recruiting)
- Local Institution - 001-884-A — Solvang, California, United States (Not_yet_recruiting)
- Kaiser Permanente - Vallejo Medical Center — Vallejo, California, United States (Recruiting)
- Local Institution - 001-850-G — Walnut Creek, California, United States (Not_yet_recruiting)
- USOR - Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States (Recruiting)
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center — Aurora, Colorado, United States (Recruiting)
- Local Institution - 001-872-H — Boulder, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-872-E — Colorado Springs, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-872-L — Colorado Springs, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-872-B — Denver, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-951 - A — Denver, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-951 - B — Denver, Colorado, United States (Not_yet_recruiting)
- Cancer Centers of Colorado - St. Marys Regional Hospital — Grand Junction, Colorado, United States (Recruiting)
- SCL Health - Saint Joseph Hospital Cancer Center — Lafayette, Colorado, United States (Recruiting)
- Local Institution - 001-872-A — Lakewood, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-872-D — Littleton, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-872-K — Lone Tree, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-872-C — Longmont, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-872-J — Parker, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-872-F — Pueblo, Colorado, United States (Not_yet_recruiting)
- Local Institution - 001-872-G — Pueblo, Colorado, United States (Not_yet_recruiting)
+178 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.