Clinical Trials

Numerous clinical trials evaluate sotorasib (AMG 510) from Early Phase 1 to Phase 4, primarily focusing on advanced KRAS p.G12C-mutated solid tumors—particularly non-small cell lung and colorectal cancers—as well as pharmacokinetic evaluations in healthy volunteers. Sponsored by pharmaceutical companies, biotech firms, and academic institutions, these studies span active, completed, and terminated recruitment statuses. Collectively, these efforts demonstrate the comprehensive clinical evaluation of sotorasib as a targeted oncological therapeutic.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06892054 RECRUITING
Pancreatic Adenocarcinoma
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
 2025-08-08 PHASE1
NCT05564377 RECRUITING
Advanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Malignant Solid Neoplasm; Malignant Female Reproductive System Neoplasm; Metastatic HER2-Negative Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Unresectable HER2-Negative Breast Carcinoma; Unresectable Malignant Solid Neoplasm
National Cancer Institute (NCI)
 2023-04-07 PHASE2
NCT07124884 NOT_YET_RECRUITING
Colorectal Carcinoma; KRAS G12C Mutation; Unresectable Colorectal Cancer
Federation Francophone de Cancerologie Digestive
 2025-08-31 PHASE2
NCT07563738 RECRUITING
Mesothelioma; Pancreatic Cancer; NSCLC (Advanced Non-small Cell Lung Cancer)
Orion Corporation, Orion Pharma
 2026-03-27 PHASE1; PHASE2
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
NCT05638295 ACTIVE_NOT_RECRUITING
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm
National Cancer Institute (NCI)
 2024-08-01 PHASE2
NCT06252649 RECRUITING
Metastatic Colorectal Cancer
Amgen
 2024-07-17 PHASE3
NCT07172919 RECRUITING
Advanced Solid Tumors
Amgen
 2026-01-02 PHASE2
NCT06807619 RECRUITING
Brain Tumor
Memorial Sloan Kettering Cancer Center
 2025-01-29 PHASE1
NCT05398094 RECRUITING
Non-small Cell Lung Cancer Stage III; KRAS P.G12C
Fundación GECP
 2022-03-21 PHASE2
NCT05631249 RECRUITING
KRAS P.G12C; Non Small Cell Lung Cancer
Gustave Roussy, Cancer Campus, Grand Paris
 2022-12-13 PHASE2
NCT07318389 NOT_YET_RECRUITING
Dynamic Tumor Resistance; Metastatic Colorectal Cancer
M.D. Anderson Cancer Center
 2026-06-10 EARLY_PHASE1
NCT05118854 ACTIVE_NOT_RECRUITING
Lung Cancer
M.D. Anderson Cancer Center
 2022-03-30 PHASE2
NCT06804824 RECRUITING
Advanced Solid Tumors
Vividion Therapeutics, Inc.
 2025-02-25 PHASE1
NCT05815173 RECRUITING
Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
NYU Langone Health
 2023-08-01 PHASE1
NCT05920356 RECRUITING
Non-Small Cell Lung Cancer (NSCLC)
Amgen
 2023-11-16 PHASE3
NCT07012031 RECRUITING
Locally Advanced Lung Non-Small Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8
National Cancer Institute (NCI)
 2026-06-17 PHASE1; PHASE2
NCT04625647 ACTIVE_NOT_RECRUITING
Lung Adenocarcinoma; Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Squamous Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8
SWOG Cancer Research Network
 2021-04-16 PHASE2
NCT04185883 ACTIVE_NOT_RECRUITING
Advanced Solid Tumors; Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Amgen
 2019-12-17 PHASE1
NCT06249282 RECRUITING
Advanced Lung Non-Small Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8
City of Hope Medical Center
 2024-04-24 PHASE1
NCT06333951 ACTIVE_NOT_RECRUITING
Thoracic Tumors; Non-small Cell Lung Cancer
Amgen
 2024-09-17 PHASE1
NCT06068153 WITHDRAWN
Metastatic Non Small Cell Lung Cancer; KRAS G12C
ETOP IBCSG Partners Foundation
 2025-03 PHASE2
NCT06582771 RECRUITING
Non Small Lung Cancer
Memorial Sloan Kettering Cancer Center
 2024-08-30 PHASE2
NCT05074810 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer; KRAS Activating Mutation
Verastem, Inc.
 2022-04-12 PHASE1; PHASE2
NCT03600883 COMPLETED
KRAS p.G12C Mutant Advanced Solid Tumors
Amgen
 2018-08-27 PHASE1; PHASE2
NCT06497556 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; KRAS G12C Lung Cancer
Hoffmann-La Roche
 2024-09-23 PHASE3
NCT05845450 RECRUITING
Colorectal Cancer; Resectable Colorectal Carcinoma
Gruppo Oncologico del Nord-Ovest
 2023-05-11 PHASE2
NCT04892017 TERMINATED
Non-Small Cell Lung Cancer; Advanced Solid Tumor; Metastatic Solid Tumor
Deciphera Pharmaceuticals, LLC
 2021-06-15 PHASE1
NCT06333678 TERMINATED
Non-Small Cell Lung Cancer
Memorial Sloan Kettering Cancer Center
 2024-03-20 PHASE2
NCT05451056 UNKNOWN
Non Small Cell Lung Cancer
Yonsei University
 2022-08-01 PHASE2
NCT05198934 COMPLETED
Colorectal Cancer (CRC)
Amgen
 2022-04-19 PHASE3
NCT06127940 UNKNOWN
Non-small Cell Lung Cancer Metastatic
Karolinska University Hospital
 2023-10-15 PHASE1
NCT04933695 TERMINATED
Non-small Cell Lung Cancer
Amgen
 2022-01-28 PHASE2
NCT05815186 WITHDRAWN
Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
NYU Langone Health
 2024-04 PHASE2
NCT04092673 UNKNOWN
Solid Tumor, Adult
Effector Therapeutics
 2019-10-25 PHASE1; PHASE2
NCT05311709 UNKNOWN
Lung Cancer; NSCLC, Stage III; NSCLC Stage IV; Lung Cancer Stage IV; Mutation; Cancer; Cancer, Lung
Vestre Viken Hospital Trust
 2022-05-30 PHASE2
NCT06061523 WITHDRAWN
Healthy Participants
Amgen
 2024-07-15 PHASE1
NCT05480865 TERMINATED
Solid Tumor, Adult; Metastatic Solid Tumor; Metastatic NSCLC; Non Small Cell Lung Cancer
Navire Pharma Inc., a BridgeBio company
 2022-07-06 PHASE1
NCT05054725 COMPLETED
Non-Small Cell Lung Cancer
Revolution Medicines, Inc.
 2021-12-30 PHASE2
NCT06061523 Withdrawn
Healthy Participants
Amgen
 2024-07-15 Phase 1
NCT06314763 COMPLETED
Drug Drug Interaction Study
Radboud University Medical Center
 2023-11-09 PHASE4
NCT05400577 WITHDRAWN
Non-Small Cell Lung Cancer
Fox Chase Cancer Center
 2022-07-13 PHASE2
NCT04720976 COMPLETED
Solid Tumor; NSCLC
Allist Pharmaceuticals, Inc.
 2021-03-23 PHASE1; PHASE2
NCT05920356 Recruiting
Non-Small Cell Lung Cancer (NSCLC)
Amgen
 2023-11-16 Phase 3
NCT06314763 Completed
Drug Drug Interaction Study
Radboud University Medical Center|Amgen
 2023-11-09 Phase 4
NCT05993455 UNKNOWN
Efficacy
Korea University Anam Hospital
 2023-07-03 PHASE2
NCT05374538 TERMINATED
Non-small Cell Lung Cancer
Vitrac Therapeutics, LLC
 2022-11-09 PHASE1
NCT05313009 TERMINATED
Non-Small Cell Lung Cancer
Medical University of South Carolina
 2022-03-07 PHASE1; PHASE2
NCT04959981 COMPLETED
Advanced Non-squamous Non-small-cell Lung Cancer
Erasca, Inc.
 2021-09-02 PHASE1
NCT05251038 WITHDRAWN
Pancreatic Cancer; Unresectable Pancreatic Cancer; Metastatic Pancreatic Cancer; KRAS P.G12C
Devalingam Mahalingam
 2022-09-13 PHASE1; PHASE2
NCT05180422 WITHDRAWN
Non Small Cell Lung Cancer
Criterium, Inc.
 2022-06-15 PHASE1; PHASE2
NCT05497557 COMPLETED
Healthy Volunteers
Amgen
 2022-07-14 PHASE1
NCT04303780 COMPLETED
KRAS p, G12c Mutated /Advanced Metastatic NSCLC
Amgen
 2020-06-04 PHASE3
NCT05327491 COMPLETED
Healthy Participants
Amgen
 2022-03-21 PHASE1
NCT05497557 Completed
Healthy Volunteers
Amgen
 2022-07-14 Phase 1
NCT04887064 COMPLETED
Hepatic Impairment
Amgen
 2021-04-22 PHASE1
NCT05048784 COMPLETED
Healthy Participants
Amgen
 2021-08-16 PHASE1
NCT04380753 COMPLETED
Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation
Amgen
 2020-04-28 PHASE1
NCT05045638 COMPLETED
Healthy Participants
Amgen
 2021-08-20 PHASE1
NCT05599828 COMPLETED
Healthy Participants
Amgen
 2020-07-17 PHASE1
NCT05571163 COMPLETED
Healthy Participants
Amgen
 2020-03-06 PHASE1
NCT05578859 COMPLETED
Healthy Subjects
Amgen
 2020-03-11 PHASE1
NCT05581992 COMPLETED
Healthy Participants
Amgen
 2020-01-06 PHASE1
NCT05568082 COMPLETED
Healthy Participants
Amgen
 2019-12-03 PHASE1
NCT05577624 COMPLETED
Healthy Participants
Amgen
 2019-11-05 PHASE1
NCT05550129 COMPLETED
Healthy Volunteers
Amgen
 2019-11-13 PHASE1
NCT05581758 COMPLETED
Healthy Participants
Amgen
 2019-11-14 PHASE1
NCT05598281 COMPLETED
Healthy Participants
Amgen
 2019-11-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-30)

Check the AMG 510 (Sotorasib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sotorasib (AMG 510) covalently binds to the cysteine residue of the GDP-bound KRAS G12C mutant protein, selectively locking the GTPase in an inactive conformation and blocking downstream RAF-MEK-ERK signaling to suppress oncogenic proliferation. This targeted inhibition leads to cell cycle arrest and apoptosis, providing the pharmacological basis for tumor growth inhibition observed in clinical trials evaluating patients with KRAS G12C-mutated non-small cell lung cancer, colorectal cancer, and advanced solid tumors.

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.