Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 3 evaluate therapies for K-Ras-associated malignancies, primarily investigating non-small cell lung cancer, metastatic colorectal cancer, neuroendocrine tumors, and ovarian cancer. Conducted by academic cooperative research organizations and industry sponsors, these active, completed, and terminated protocols assess diagnostic markers, gene mutation status, and targeted combination regimens.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07431827 RECRUITING
Non-small Cell Lung Cancer
Merck Sharp & Dohme LLC
 2026-03-18 PHASE3
NCT07554339 RECRUITING
Non-small Cell Lung Cancer
Merck Sharp & Dohme LLC
 2026-06-18 PHASE3
NCT07209111 RECRUITING
Neoplasm Malignant
Merck Sharp & Dohme LLC
 2025-12-04 PHASE2
NCT07541170 RECRUITING
Non-small Cell Lung Cancer
Hoffmann-La Roche
 2026-09-01 PHASE3
NCT05789082 RECRUITING
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2023-06-20 PHASE1; PHASE2
NCT06645236 RECRUITING
Metastatic Colorectal Cancer (mCRC)
QIAGEN Gaithersburg, Inc
 2023-12-22
NCT07124884 NOT_YET_RECRUITING
Colorectal Carcinoma; KRAS G12C Mutation; Unresectable Colorectal Cancer
Federation Francophone de Cancerologie Digestive
 2025-08-31 PHASE2
NCT07639242 SUSPENDED
Lung Cancer; Lung Cancer (NSCLC); Locally Advanced NSCLC; Metastatic NSCLC - Non-Small Cell Lung Cancer
UNC Lineberger Comprehensive Cancer Center
 2026-10 PHASE2
NCT05067283 RECRUITING
Advanced Solid Tumors
Merck Sharp & Dohme LLC
 2021-12-17 PHASE1
NCT07190248 RECRUITING
Non-small Cell Lung Cancer
Merck Sharp & Dohme LLC
 2025-10-08 PHASE3
NCT07542704 NOT_YET_RECRUITING
Advanced Solid Tumors; Colorectal Cancer (CRC); Non-Small Cell Lung Cancer; Uterine Cancer; KRAS G12C Mutations; KRAS G12S Mutations
Kumquat Biosciences Inc.
 2026-05 PHASE1
NCT07252739 RECRUITING
Malignant Neoplasm
Merck Sharp & Dohme LLC
 2025-12-19 PHASE2
NCT06875310 RECRUITING
Carcinoma, Non-Small-Cell Lung
Mirati Therapeutics Inc.
 2025-04-24 PHASE3
NCT07286149 RECRUITING
Lung Neoplasm Malignant
Merck Sharp & Dohme LLC
 2026-04-30 PHASE1; PHASE2
NCT06720987 RECRUITING
KRAS G12C Mutation; KRAS G12S Mutation; Solid Tumor Malignancies; CRC (Colorectal Cancer)
Kumquat Biosciences Inc.
 2025-02-04 PHASE1
NCT07615413 NOT_YET_RECRUITING
KRAS G12C Mutation Advanced Solid Tumor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
 2026-06-30 PHASE1
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
NCT06890598 RECRUITING
Carcinoma, Non-Small-Cell Lung
Eli Lilly and Company
 2025-03-27 PHASE3
NCT06997497 RECRUITING
Colon Adenocarcinoma; Rectal Adenocarcinoma
Merck Sharp & Dohme LLC
 2025-07-16 PHASE3
NCT06412198 RECRUITING
Metastatic Colorectal Cancer; KRAS G12C Mutations
M.D. Anderson Cancer Center
 2024-08-28 PHASE1; PHASE2
NCT06345729 RECRUITING
Non-small Cell Lung Cancer
Merck Sharp & Dohme LLC
 2024-05-24 PHASE3
NCT07164170 RECRUITING
Non-Small Cell Lung Cancer
Abbisko Therapeutics Co, Ltd
 2025-09-22 PHASE2
NCT06128551 RECRUITING
Non-Small Cell Lung Cancer (NSCLC); Colorectal Cancer; Pancreatic Ductal Adenocarcinoma
Revolution Medicines, Inc.
 2023-11-14 PHASE1; PHASE2
NCT07589569 RECRUITING
Pancreatic Cancer
Shandong Suncadia Medicine Co., Ltd.
 2026-06-04 PHASE2
NCT07581912 RECRUITING
Colorectal Cancer; KRAS G12C Mutant Advanced Solid Tumors; Fulzerasib; Cetuximab N01
Zhejiang University
 2026-04-30 PHASE2
NCT06793215 RECRUITING
Non-Small Cell Lung Cancer; KRAS G12C Lung Cancer
Hoffmann-La Roche
 2025-10-24 PHASE3
NCT04613596 RECRUITING
Advanced Non-Small Cell Lung Cancer; Metastatic Non-Small Cell Lung Cancer
Mirati Therapeutics Inc.
 2020-12-02 PHASE2; PHASE3
NCT07294261 NOT_YET_RECRUITING
Local Advanced or Metastatic NSCLC
Sun Yat-sen University
 2025-12-23 PHASE2
NCT07174908 RECRUITING
Non-Small Cell Lung Cancer
InxMed (Shanghai) Co., Ltd.
 2025-09-10 PHASE3
NCT07601048 NOT_YET_RECRUITING
KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
Shandong Suncadia Medicine Co., Ltd.
 2026-06 PHASE3
NCT07670013 RECRUITING
NSCLC
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2026-04-01 PHASE2
NCT05398094 RECRUITING
Non-small Cell Lung Cancer Stage III; KRAS P.G12C
Fundación GECP
 2022-03-21 PHASE2
NCT07472478 NOT_YET_RECRUITING
Lung Cancer (NSCLC); KRAS G12C Lung Cancer
Guangdong Provincial People's Hospital
 2026-03-15 PHASE2
NCT04449874 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; Colorectal Cancer; Advanced Solid Tumors
Genentech, Inc.
 2020-07-29 PHASE1
NCT06166836 ACTIVE_NOT_RECRUITING
Solid Tumor
InxMed (Shanghai) Co., Ltd.
 2022-10-12 PHASE1; PHASE2
NCT07242274 NOT_YET_RECRUITING
NSCLC (Non-small Cell Lung Cancer)
Jemincare
 2025-12-31 PHASE3
NCT06119581 RECRUITING
Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis
Eli Lilly and Company
 2023-12-21 PHASE3
NCT06244771 RECRUITING
Advanced Solid Tumors With KRAS G12C Mutations; Solid Tumor, Adult; Unresectable Solid Tumor; Metastatic Solid Tumor; Non Small Cell Lung Cancer; Colorectal Cancer; KRAS G12C; Pancreatic Cancer
Frontier Medicines Corporation
 2024-02-12 PHASE1; PHASE2
NCT06435455 NOT_YET_RECRUITING
Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
Suzhou Genhouse Bio Co., Ltd.
 2024-07-01 PHASE1; PHASE2
NCT07339839 NOT_YET_RECRUITING
NSCLC Stage IV; KRAS G12C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2026-03-01 PHASE1; PHASE2
NCT07198841 RECRUITING
Lung Cancer (Non-Small Cell)
Guangdong Association of Clinical Trials
 2025-11-03 PHASE2
NCT05815173 RECRUITING
Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
NYU Langone Health
 2023-08-01 PHASE1
NCT05999357 WITHDRAWN
Non Small Cell Lung Cancer Metastatic; Brain Metastases, Adult; KRAS G12C
Maastricht University Medical Center
 2024-04-15 PHASE2
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
NCT06959589 ENROLLING_BY_INVITATION
Colorectal Cancer Metastatic; KRAS G12C Mutation
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2025-05-22 PHASE2
NCT06936644 NOT_YET_RECRUITING
KRAS G12C Lung Cancer
Shanghai Chest Hospital
 2025-04-30 PHASE2
NCT04956640 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Biliary Tract Neoplasms
Eli Lilly and Company
 2021-07-19 PHASE1; PHASE2
NCT05288205 RECRUITING
KRAS P.G12C; Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Ductal Carcinoma
Allist Pharmaceuticals, Inc.
 2022-04-14 PHASE1; PHASE2
NCT06248606 RECRUITING
Non Small Cell Lung Cancer; NSCLC; KRAS G12C
Ryan Gentzler, MD
 2024-08-06 PHASE2
NCT04699188 ACTIVE_NOT_RECRUITING
KRAS G12C Mutant Solid Tumors; Carcinoma, Non-Small-Cell Lung; Carcinoma, Colorectal; Cancer of Lung; Cancer of the Lung; Lung Cancer; Neoplasms, Lung; Neoplasms, Pulmonary; Pulmonary Cancer; Pulmonary Neoplasms
Novartis Pharmaceuticals
 2021-02-24 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
NCT05485974 ACTIVE_NOT_RECRUITING
Lung Cancer; Non Small Cell Lung Cancer; Colorectal Cancer; Cancer of Pancreas; Colon Cancer; Solid Tumor; Cancer
HUYABIO International, LLC.
 2022-08-01 PHASE1
NCT04973163 ACTIVE_NOT_RECRUITING
Solid Tumors, KRAS Mutation
Boehringer Ingelheim
 2021-09-09 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
NCT06594874 NOT_YET_RECRUITING
Non-Small Cell Lung Cancer; Advanced Solid Tumors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
 2024-10-31 PHASE1
NCT07396090 NOT_YET_RECRUITING
Advanced Solid Tumor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2026-01-20
NCT05853575 ACTIVE_NOT_RECRUITING
Advanced Cancer; Metastatic Cancer; Malignant Neoplasm of Lung
Mirati Therapeutics Inc.
 2024-02-01 PHASE2
NCT06300177 RECRUITING
Non Small Cell Lung Cancer
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2024-03-28 PHASE3
NCT05358249 ACTIVE_NOT_RECRUITING
KRAS G12C Mutant Solid Tumors; Carcinoma, Non-Small Cell Lung; Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer; Non-Small Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Colorectal Cancer; Colorectal Carcinoma; Colorectal Neoplasms; Colorectal Tumors; Neoplasms, Colorectal
Novartis Pharmaceuticals
 2022-10-24 PHASE1; PHASE2
NCT05609578 ACTIVE_NOT_RECRUITING
Advanced NSCLC; Metastatic Lung Cancer
Mirati Therapeutics Inc.
 2022-11-22 PHASE2
NCT06068153 WITHDRAWN
Metastatic Non Small Cell Lung Cancer; KRAS G12C
ETOP IBCSG Partners Foundation
 2025-03 PHASE2
NCT05132075 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals
 2022-06-15 PHASE3
NCT06582771 RECRUITING
Non Small Lung Cancer
Memorial Sloan Kettering Cancer Center
 2024-08-30 PHASE2
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
NCT06383871 RECRUITING
Advanced Malignant Tumour
Shandong Suncadia Medicine Co., Ltd.
 2024-06-06 PHASE1
NCT05074810 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer; KRAS Activating Mutation
Verastem, Inc.
 2022-04-12 PHASE1; PHASE2
NCT06497556 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; KRAS G12C Lung Cancer
Hoffmann-La Roche
 2024-09-23 PHASE3
NCT06838338 ACTIVE_NOT_RECRUITING
Colorectal Cancer
Jian Li
 2025-03-20 PHASE1
NCT06946927 RECRUITING
NSCLC (Advanced Non-small Cell Lung Cancer)
Jemincare
 2025-06-06 PHASE1
NCT06333678 TERMINATED
Non-Small Cell Lung Cancer
Memorial Sloan Kettering Cancer Center
 2024-03-20 PHASE2
NCT04793958 ACTIVE_NOT_RECRUITING
Advanced Colorectal Cancer; Metastatic Colorectal Cancer
Mirati Therapeutics Inc.
 2021-06-24 PHASE3
NCT05451056 UNKNOWN
Non Small Cell Lung Cancer
Yonsei University
 2022-08-01 PHASE2
NCT05634525 WITHDRAWN
Metastatic Pancreatic Cancer
M.D. Anderson Cancer Center
 2023-05-03 PHASE1
NCT06235983 COMPLETED
Advanced Solid Tumors
Eli Lilly and Company
 2024-02-29 PHASE1
NCT05472623 WITHDRAWN
Resectable Non-Small Cell Lung Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2023-03-21 PHASE2
NCT06127940 UNKNOWN
Non-small Cell Lung Cancer Metastatic
Karolinska University Hospital
 2023-10-15 PHASE1
NCT05504278 RECRUITING
Advanced Non-Small Cell Lung Cancer
Innovent Biologics (Suzhou) Co. Ltd.
 2022-09-20 PHASE1
NCT04933695 TERMINATED
Non-small Cell Lung Cancer
Amgen
 2022-01-28 PHASE2
NCT06237400 UNKNOWN
KRAS G12C Mutant Advanced Solid Tumors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
 2022-05-26 PHASE1; PHASE2
NCT05194995 ACTIVE_NOT_RECRUITING
Advanced Colorectal Cancer; Small Intestinal Cancer; Appendiceal Cancer
Allist Pharmaceuticals, Inc.
 2022-02-17 PHASE1; PHASE2
NCT05756153 COMPLETED
Advance Non-small Cell Lung Cancer
Genfleet Therapeutics (Shanghai) Inc.
 2023-04-25 PHASE1; PHASE2
NCT05815186 WITHDRAWN
Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
NYU Langone Health
 2024-04 PHASE2
NCT05002270 COMPLETED
Advanced Solid Tumor; NSCLC; CRC
Jacobio Pharmaceuticals Co., Ltd.
 2021-09-03 PHASE1; PHASE2
NCT05497336 TERMINATED
Colorectal Cancer
Innovent Biologics (Suzhou) Co. Ltd.
 2022-08-18 PHASE1
NCT05840510 TERMINATED
Solid Tumor, Adult; NSCLC; Advanced Cancer; Metastatic Cancer; Malignant Neoplastic Disease
Mirati Therapeutics Inc.
 2023-08-07 PHASE1
NCT05445843 ACTIVE_NOT_RECRUITING
Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation
Novartis Pharmaceuticals
 2022-12-06 PHASE2
NCT06117371 COMPLETED
Advanced or Metastatic Solid Tumor; KRAS G12C Mutation
BeBetter Med Inc
 2023-09-18 PHASE1
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
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
NCT06130254 TERMINATED
Advanced Solid Tumor; Non-small Cell Lung Cancers
M.D. Anderson Cancer Center
 2024-01-30 PHASE1
NCT05492045 TERMINATED
NSCLC
InventisBio Co., Ltd
 2022-09-13 PHASE1; PHASE2
NCT06024174 TERMINATED
Advanced Solid Tumors
Bristol-Myers Squibb
 2023-11-09 PHASE1; PHASE2
NCT04585035 ACTIVE_NOT_RECRUITING
Solid Tumor, Adult; NSCLC; CRC
InventisBio Co., Ltd
 2020-10-02 PHASE1; PHASE2
NCT05848843 WITHDRAWN
Lung Cancer; Gastro-intestinal Cancer
M.D. Anderson Cancer Center
 2023-04-25 PHASE1
NCT05400577 WITHDRAWN
Non-Small Cell Lung Cancer
Fox Chase Cancer Center
 2022-07-13 PHASE2
NCT04685135 ACTIVE_NOT_RECRUITING
Metastatic Non Small Cell Lung Cancer; Advanced Non Small Cell Lung Cancer
Mirati Therapeutics Inc.
 2021-02-23 PHASE3
NCT05263986 UNKNOWN
Advanced or Metastatic Solid Tumor
Zai Lab (Shanghai) Co., Ltd.
 2022-05-30 PHASE1
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
NCT04967079 COMPLETED
Non Small Cell Lung Cancer
Shanghai Chest Hospital
 2021-08-01 PHASE1
NCT05178888 COMPLETED
Advanced Solid Tumor
Mirati Therapeutics Inc.
 2022-01-20 PHASE1
NCT05119933 UNKNOWN
Advanced Solid Tumor
Shanghai YingLi Pharmaceutical Co. Ltd.
 2021-11-09 PHASE1; PHASE2
NCT05347745 COMPLETED
Colo-rectal Cancer
QIAGEN Gaithersburg, Inc
 2022-01-07
NCT05010694 UNKNOWN
Advanced Solid Tumors Harboring With G12C Mutation
Suzhou Genhouse Bio Co., Ltd.
 2021-09-27 PHASE1
NCT05005234 COMPLETED
KRAS G12C
Innovent Biologics (Suzhou) Co. Ltd.
 2021-09-13 PHASE1; PHASE2
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
NCT04975256 TERMINATED
Advanced Cancer; Metastatic Cancer; Malignant Neoplasm of Colon; Malignant Neoplasm of Lung; Malignant Neoplastic Disease
Mirati Therapeutics Inc.
 2021-07-28 PHASE1
NCT04330664 COMPLETED
Advanced Cancer; Metastatic Cancer; Malignant Neoplastic Disease
Mirati Therapeutics Inc.
 2020-04-07 PHASE1
NCT04236102 COMPLETED
Pancreatic Adenocarcinoma; Lung Cancer
Royal Cornwall Hospitals Trust
 2020-07-07
NCT02395016 COMPLETED
Pancreatic Cancer
Biotech Pharmaceutical Co., Ltd.
 2015-04 PHASE3
NCT01079780 COMPLETED
Colorectal Cancer
Eastern Cooperative Oncology Group
 2011-01-18 PHASE2
NCT04165031 TERMINATED
Advanced Solid Tumor; Non-Small Cell Lung Cancer; Colorectal Cancer
Eli Lilly and Company
 2019-11-28 PHASE1; PHASE2
NCT04006301 COMPLETED
Neoplasms; Advanced Solid Tumors; Non-small Cell Lung Cancer; Colorectal Cancer
Janssen Research & Development, LLC
 2019-07-26 PHASE1
NCT01802645 UNKNOWN
Colorectal Cancer
Technische Universität Dresden
 2013-03 PHASE2
NCT04342676 COMPLETED
Colon Cancer Stage III
Mansoura University
 2017-03-10 PHASE3
NCT01051167 COMPLETED
Metastatic Colorectal Cancer
Martin Schuler, Prof. Dr. med.
 2009-02 PHASE2
NCT01251536 COMPLETED
Colorectal Cancer
Universitaire Ziekenhuizen KU Leuven
 2010-12 PHASE2
NCT01646554 WITHDRAWN
Colorectal Cancer Metastatic; Liver Metastases; KRAS Mutated Colorectal Cancer
European Organisation for Research and Treatment of Cancer - EORTC
 2012-12 PHASE2; PHASE3
NCT01540344 TERMINATED
Peritoneal Carcinomatosis; Colorectal Cancer Metastatic
University of Regensburg
 2010-10 PHASE2
NCT01410214 UNKNOWN
Non-small Cell Lung Cancer Stage IIIA
Chinese Lung Cancer Surgical Group
 2011-05 PHASE2
NCT01338558 WITHDRAWN
Colorectal Cancer
Hoffmann-La Roche
 2011-06 PHASE3
NCT01008475 COMPLETED
Metastatic Colorectal Cancer
Merck KGaA, Darmstadt, Germany
 2009-10 PHASE1; PHASE2
NCT01288339 COMPLETED
Metastatic Colorectal Cancer
Grupo Espanol Multidisciplinario del Cancer Digestivo
 2010-11-08 PHASE2
NCT01042288 COMPLETED
Non-Small-Cell Lung Cancer
SCRI Development Innovations, LLC
 2010-06 PHASE2
NCT01450319 COMPLETED
Colorectal Neoplasms
Merck KGaA, Darmstadt, Germany
 2011-12 PHASE2
NCT01215539 COMPLETED
Colorectal Cancer
Hellenic Cooperative Oncology Group
 2010-09 PHASE2
NCT01126112 COMPLETED
Colorectal Cancer
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
 2010-05 PHASE2
NCT00941499 COMPLETED
Advanced Cancers
M.D. Anderson Cancer Center
 2009-07 PHASE1
NCT00655161 COMPLETED
NSCLC
GlobeImmune
 2008-04 PHASE2
NCT05278728 COMPLETED
Colorectal Cancer
Biotech Pharmaceutical Co., Ltd.
 2009-07 PHASE1; PHASE2
NCT00803647 COMPLETED
Metastatic Colorectal Cancer
NSABP Foundation Inc
 2010-01 PHASE2
NCT00869570 COMPLETED
Colorectal Cancer
Swiss Cancer Institute
 2009-03 PHASE1; PHASE2
NCT01277406 COMPLETED
Advanced Colorectal Carcinoma
4SC AG
 2011-01 PHASE1; PHASE2
NCT01060423 TERMINATED
Colorectal Cancer
Hans-Joachim Schmoll, MD
 2010-02 PHASE2
NCT00594984 COMPLETED
Metastatic Colorectal Cancer (MCRC)
Bristol-Myers Squibb
 2008-05 PHASE1; PHASE2
NCT01281761 COMPLETED
Metastatic Colorectal Cancer
Samsung Medical Center
 2010-11 PHASE2
NCT01149434 TERMINATED
Cancer; Neuroendocrine; Ovarian Cancer; Colon Cancer
University of Utah
 2010-09 PHASE1; PHASE2
NCT01190462 UNKNOWN
Colorectal Cancer
Leiden University Medical Center
 2010-08 PHASE2
NCT00964457 UNKNOWN
Rectum Cancer
Copenhagen University Hospital at Herlev
 2009-08 PHASE2
NCT01116271 COMPLETED
Colorectal Cancer
AstraZeneca
 2010-04 PHASE2
NCT01085331 TERMINATED
Metastatic Colorectal Cancer
EMD Serono
 2010-03 PHASE1; PHASE2
NCT01110785 UNKNOWN
Colorectal Cancer
Leiden University Medical Center
 2010-04 PHASE2
NCT00640471 COMPLETED
Colorectal Cancer
NCIC Clinical Trials Group
 2008-05-12 PHASE3
NCT01086267 COMPLETED
Colorectal Cancer
Bristol-Myers Squibb
 2010-07 PHASE1; PHASE2
NCT00660582 COMPLETED
Metastatic Colorectal Cancer
Per Pfeiffer
 2008-04 PHASE2
NCT01380795 TERMINATED
Non-small Cell Lung Cancer Metastatic
Centre Georges Francois Leclerc
 2011-03-09 EARLY_PHASE1
NCT00845039 TERMINATED
Colon Cancer; Rectal Cancer
Eli Lilly and Company
 2009-05 PHASE2
NCT00989469 COMPLETED
Metastatic Colorectal Cancer
Institut du Cancer de Montpellier - Val d'Aurelle
 2009-02 PHASE1; PHASE2
NCT01032291 TERMINATED
Colorectal Cancer
Celgene Corporation
 2009-12 PHASE2
NCT01126450 TERMINATED
Colon Cancer; Rectal Cancer
Case Comprehensive Cancer Center
 2009-10 PHASE1
NCT00640081 COMPLETED
Colorectal Cancer
Cheryl Pugh
 2007-07 PHASE2
NCT00814619 COMPLETED
Colorectal Cancer
Swiss Cancer Institute
 2008-11 PHASE2
NCT00972465 UNKNOWN
Advanced Colorectal Cancer
Peking University
 2009-06 PHASE2
NCT00005630 COMPLETED
Lung Cancer
Memorial Sloan Kettering Cancer Center
 1999-07 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the K-Ras(G12C) inhibitor 12 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

K-Ras(G12C) inhibitor 12 selectively binds allosterically to the mutant GTPase K-Ras(G12C), locking the protein in an inactive GDP-bound conformation and preventing downstream MAPK and PI3K/AKT signaling cascades. By suppressing hyperactive proliferative pathways and inducing apoptotic signaling, this targeted inhibition halts tumor cell growth in oncogenic driver settings such as non-small cell lung cancer and colorectal cancer.

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.