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

NCT03785249 · tracked via the Priya Life Science USA tracker

Sponsor

Mirati Therapeutics Inc.

Phase

Phase 1/2

Started

2019-01-15

Last updated

2026-07-29

Condition(s) studied

Advanced CancerMetastatic CancerMalignant Neoplastic Disease

Investigational drug(s) / intervention(s)

MRTX849PembrolizumabCetuximabAfatinib

MRTX849: MRTX849 will be administered orally once or twice daily in a continuous regimen

Pembrolizumab: Pembrolizumab is administered as an intravenous infusion once every 3 weeks

Cetuximab: Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks

Afatinib: Afatinib will be administered orally once a day in a continuous regimen

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation — 20 months
Number of participants with treatment related adverse events
Evaluate the pharmacokinetics of MRTX849 — 20 months
Blood plasma concentration
Evaluate clinical activity/efficacy of MRTX849 — 20 months
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

Trial sites (222)

Facility	City	Region
Local Institution - 001-826	Birmingham	Alabama
Local Institution - 001-965	Anchorage	Alaska
Local Institution - 001-821	Phoenix	Arizona
Local Institution - 001-873-A	Tucson	Arizona
Local Institution - 001-873	Tucson	Arizona
Local Institution - 001-840-B	Bellflower	California
Local Institution - 001-834	Beverly Hills	California
Local Institution - 001-843	Duarte	California
Local Institution - 001-850-K	Dublin	California
Local Institution - 001-851	Fullerton	California
Local Institution - 001-840-C	Harbor City	California
Local Institution - 001-805	La Jolla	California
Local Institution - 001-779	Los Alamitos	California
Local Institution - 001-840	Los Angeles	California
Local Institution - 001-578	Los Angeles	California
Local Institution - 001-847	Newport Beach	California
Local Institution - 001-850-B	Oakland	California
Local Institution - 001-803	Orange	California
Local Institution - 001-850-C	Roseville	California
Local Institution - 001-850-J	Sacramento	California
Local Institution - 001-850-D	Sacramento	California
Local Institution - 001-845	San Diego	California
Local Institution - 001-840-A	San Diego	California
Local Institution - 001-850-H	San Francisco	California
Local Institution - 001-850-E	San Francisco	California
Local Institution - 001-850-F	San Jose	California
Local Institution - 001-850-A	San Leandro	California
Local Institution - 001-884	Santa Barbara	California
Local Institution - 001-850-I	Santa Clara	California
Local Institution - 001-884-A	Solvang	California
Local Institution - 001-850	Vallejo	California
Local Institution - 001-850-G	Walnut Creek	California
Local Institution - 001-872	Aurora	Colorado
Local Institution - 001-810	Aurora	Colorado
Local Institution - 001-872-H	Boulder	Colorado
Local Institution - 001-872-E	Colorado Springs	Colorado
Local Institution - 001-872-L	Colorado Springs	Colorado
Local Institution - 001-872-B	Denver	Colorado
Local Institution - 001-951 - A	Denver	Colorado
Local Institution - 001-951 - B	Denver	Colorado

+ 182 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Mirati Therapeutics Inc. trials in the USA

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation Active, not recruiting

Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21) Active, not recruiting

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4) Recruiting

Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation Active, not recruiting

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) Active, not recruiting

Other trials for the same condition

A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors Active, not recruiting

CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer Starting soon

Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21) Active, not recruiting

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors Recruiting

Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03785249 on ClinicalTrials.gov ↗ ← All trials in the USA