Clinical Trials

Numerous clinical trials evaluate the therapeutic profile and pharmacokinetics of adagrasib (MRTX849) across phase 1 through phase 3 studies, assessing monotherapy and combination regimens with targeted agents and immunotherapies. These studies focus on KRAS G12C-mutated malignancies—such as non-small cell lung cancer, colorectal cancer, and advanced solid tumors—and drug interactions in healthy participants. Featuring recruitment statuses from recruiting to completed and terminated, these trials are sponsored by industry leaders including Mirati Therapeutics, Incyte, and Hoffmann-La Roche, alongside academic partners like M.D. Anderson Cancer Center.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06875310 RECRUITING
Carcinoma, Non-Small-Cell Lung
Mirati Therapeutics Inc.
 2025-04-24 PHASE3
NCT07543172 NOT_YET_RECRUITING
Advanced Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8
Roswell Park Cancer Institute
 2026-10-15 PHASE2
NCT06412198 RECRUITING
Metastatic Colorectal Cancer; KRAS G12C Mutations
M.D. Anderson Cancer Center
 2024-08-28 PHASE1; PHASE2
NCT04613596 RECRUITING
Advanced Non-Small Cell Lung Cancer; Metastatic Non-Small Cell Lung Cancer
Mirati Therapeutics Inc.
 2020-12-02 PHASE2; PHASE3
NCT07288034 RECRUITING
Lung Non-Small Cell Carcinoma; Stage IIIB Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8
City of Hope Medical Center
 2026-04-08 PHASE2
NCT07415031 RECRUITING
Solid Tumors
Mirati Therapeutics Inc.
 2026-05-06 PHASE2
NCT07382726 RECRUITING
Non-small Cell Lung Cancer
M.D. Anderson Cancer Center
 2026-05-15 PHASE1
NCT07318389 NOT_YET_RECRUITING
Dynamic Tumor Resistance; Metastatic Colorectal Cancer
M.D. Anderson Cancer Center
 2026-06-10 EARLY_PHASE1
NCT06764771 RECRUITING
Advanced Malignant Tumors
Bristol-Myers Squibb
 2025-03-25 PHASE1
NCT05722327 ACTIVE_NOT_RECRUITING
Colon Cancer; Colorectal Cancer
M.D. Anderson Cancer Center
 2023-12-06 PHASE1
NCT06248606 RECRUITING
Non Small Cell Lung Cancer; NSCLC; KRAS G12C
Ryan Gentzler, MD
 2024-08-06 PHASE2
NCT06026410 RECRUITING
Solid Tumors With HRAS Alterations; Non Small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC); Clear Cell Renal Cell Carcinoma (ccRCC); Renal Cell Carcinoma (Kidney Cancer); Non Clear Cell Renal Cell Carcinoma (nccRCC)
Kura Oncology, Inc.
 2023-10-18 PHASE1
NCT05853575 ACTIVE_NOT_RECRUITING
Advanced Cancer; Metastatic Cancer; Malignant Neoplasm of Lung
Mirati Therapeutics Inc.
 2024-02-01 PHASE2
NCT03994796 ACTIVE_NOT_RECRUITING
CDK Gene Mutation; Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm; NTRK Family Gene Mutation; PI3K Gene Mutation; ROS1 Gene Mutation; KRAS G12C Mutation
Alliance for Clinical Trials in Oncology
 2019-10-17 PHASE2
NCT05609578 ACTIVE_NOT_RECRUITING
Advanced NSCLC; Metastatic Lung Cancer
Mirati Therapeutics Inc.
 2022-11-22 PHASE2
NCT07723118 RECRUITING
Healthy Participants
Mirati Therapeutics Inc.
 2026-08-05 PHASE1
NCT03785249 ACTIVE_NOT_RECRUITING
Advanced Cancer; Metastatic Cancer; Malignant Neoplastic Disease
Mirati Therapeutics Inc.
 2019-01-15 PHASE1; PHASE2
NCT05375994 COMPLETED
Non Small Cell Lung Cancer; KRAS Activating Mutation; Advanced Cancer; Metastatic Cancer; Malignant Neoplasm of Lung; Malignant Neoplastic Disease
Verastem, Inc.
 2022-08-01 PHASE1; PHASE2
NCT06497556 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; KRAS G12C Lung Cancer
Hoffmann-La Roche
 2024-09-23 PHASE3
NCT05578092 TERMINATED
Solid Tumor; Advanced Solid Tumor; Non Small Cell Lung Cancer; Colo-rectal Cancer
Mirati Therapeutics Inc.
 2022-12-02 PHASE1
NCT04793958 ACTIVE_NOT_RECRUITING
Advanced Colorectal Cancer; Metastatic Colorectal Cancer
Mirati Therapeutics Inc.
 2021-06-24 PHASE3
NCT05673187 ACTIVE_NOT_RECRUITING
NSCLC Stage IV; KRAS P.G12C
ETOP IBCSG Partners Foundation
 2023-06-12 PHASE2
NCT05634525 WITHDRAWN
Metastatic Pancreatic Cancer
M.D. Anderson Cancer Center
 2023-05-03 PHASE1
NCT06801418 COMPLETED
Healthy Volunteers
Mirati Therapeutics Inc.
 2025-02-04 PHASE1
NCT05472623 WITHDRAWN
Resectable Non-Small Cell Lung Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2023-03-21 PHASE2
NCT06039384 TERMINATED
Advanced Solid Tumors
Incyte Corporation
 2023-12-28 PHASE1
NCT05840510 TERMINATED
Solid Tumor, Adult; NSCLC; Advanced Cancer; Metastatic Cancer; Malignant Neoplastic Disease
Mirati Therapeutics Inc.
 2023-08-07 PHASE1
NCT06130254 TERMINATED
Advanced Solid Tumor; Non-small Cell Lung Cancers
M.D. Anderson Cancer Center
 2024-01-30 PHASE1
NCT06024174 TERMINATED
Advanced Solid Tumors
Bristol-Myers Squibb
 2023-11-09 PHASE1; PHASE2
NCT04418661 TERMINATED
Metastatic Neoplasm
Sanofi
 2020-06-09 PHASE1; PHASE2
NCT05853575 Recruiting
Advanced Cancer|Metastatic Cancer|Malignant Neoplasm of Lung
Mirati Therapeutics Inc.
 2024-02-01 Phase 2
NCT05848843 WITHDRAWN
Lung Cancer; Gastro-intestinal Cancer
M.D. Anderson Cancer Center
 2023-04-25 PHASE1
NCT04685135 ACTIVE_NOT_RECRUITING
Metastatic Non Small Cell Lung Cancer; Advanced Non Small Cell Lung Cancer
Mirati Therapeutics Inc.
 2021-02-23 PHASE3
NCT06039384 Recruiting
Advanced Solid Tumors
Incyte Corporation|Mirati Therapeutics Inc.
 2023-12-28 Phase 1
NCT05263986 UNKNOWN
Advanced or Metastatic Solid Tumor
Zai Lab (Shanghai) Co., Ltd.
 2022-05-30 PHASE1
NCT05924152 COMPLETED
Healthy Adults
Mirati Therapeutics Inc.
 2023-06-29 PHASE1
NCT05868356 COMPLETED
Healthy Adults
Mirati Therapeutics Inc.
 2023-06-01 PHASE1
NCT05178888 COMPLETED
Advanced Solid Tumor
Mirati Therapeutics Inc.
 2022-01-20 PHASE1
NCT05924152 Completed
Healthy Adults
Mirati Therapeutics Inc.
 2023-06-29 Phase 1
NCT05868356 Completed
Healthy Adults
Mirati Therapeutics Inc.
 2023-06-01 Phase 1
NCT04975256 TERMINATED
Advanced Cancer; Metastatic Cancer; Malignant Neoplasm of Colon; Malignant Neoplasm of Lung; Malignant Neoplastic Disease
Mirati Therapeutics Inc.
 2021-07-28 PHASE1
NCT05375994 Recruiting
Non Small Cell Lung Cancer|KRAS Activating Mutation|Advanced Cancer|Metastatic Cancer|Malignant Neoplasm of Lung|Malignant Neoplastic Disease
Verastem Inc.|Mirati Therapeutics Inc.
 2022-08-01 Phase 1|Phase 2
NCT04330664 COMPLETED
Advanced Cancer; Metastatic Cancer; Malignant Neoplastic Disease
Mirati Therapeutics Inc.
 2020-04-07 PHASE1
NCT04685135 Active not recruiting
Metastatic Non Small Cell Lung Cancer|Advanced Non Small Cell Lung Cancer
Mirati Therapeutics Inc.
 2021-04-01 Phase 3

(data from https://clinicaltrials.gov, updated on 2026-09-01)

Check the Adagrasib (MRTX849) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Adagrasib (MRTX849) is a selective, covalent inhibitor that specifically targets and modifies the mutant cysteine 12 residue in GDP-bound KRAS G12C, locking the protein in an inactive conformation. By blocking nucleotide exchange and disrupting downstream effector signaling through RAF and MAPK cascades, adagrasib suppresses tumor cell proliferation and induces apoptosis in KRAS G12C-driven malignancies, including non-small cell lung and colorectal cancers.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.