Defactinib (VS-6063) Clinical Trials

Size	Price	Qty
5mg	USD 177
25mg	USD 377

Clinical Trials

Defactinib (VS-6063) has been evaluated across multiple clinical trials spanning Early Phase 1 through Phase 3, encompassing phase 1 pharmacology studies in healthy volunteers alongside oncology indications such as advanced lung adenocarcinoma, pancreatic cancer, low-grade serous ovarian carcinoma, thyroid cancer, malignant pleural mesothelioma, and refractory solid neoplasms. Supported by sponsors including Verastem, Inc., the National Cancer Institute, and academic institutions such as Emory University, Washington University School of Medicine, and Memorial Sloan Kettering Cancer Center, trial recruitment statuses range from actively recruiting and completed to active, not recruiting and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07743554	NOT_YET_RECRUITING	MPNST (Malignant Peripheral Nerve Sheath Tumor)	Girish Dhall, MD	2027-01-01	PHASE2
NCT07126158	RECRUITING	Pancreatic Adenocarcinoma; Cancer of the Pancreas; Pancreas Cancer; Pancreatic Cancer	Washington University School of Medicine	2026-04-10	PHASE2
NCT06104488	ACTIVE_NOT_RECRUITING	Refractory Cancer; CNS Tumors; CNS Tumor, Adult; CNS Tumor, Childhood; MAP Kinase Family Gene Mutation; NF1; Plexiform Neurofibroma; Low-grade Glioma; Optic Pathway Gliomas; Neuroblastoma; Primary Brain Tumor; Solid Tumor; Solid Tumor, Adult; Solid Carcinoma; Central Nervous System Tumor	Memorial Sloan Kettering Cancer Center	2023-10-20	PHASE1
NCT06630260	RECRUITING	Glioblastoma Multiforme (GBM); Glioblastoma Multiform (Grade IV Astrocytoma); Diffuse Hemispheric Glioma, H3 G34-Mutant; Malignant Primary Gliomas	Institute of Cancer Research, United Kingdom	2024-11-15	PHASE1; PHASE2
NCT06495125	RECRUITING	Advanced Lung Adenocarcinoma; Refractory Lung Adenocarcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8	Emory University	2024-07-31	PHASE2
NCT06369259	RECRUITING	Advanced Colorectal Cancer	M.D. Anderson Cancer Center	2025-02-24	PHASE2
NCT06487221	RECRUITING	Gastric Cancer; Stomach Cancer	Ryan H. Moy, MD, PhD	2024-10-28	PHASE2
NCT07778602	NOT_YET_RECRUITING	MGMT-unmethylated Glioblastoma (GBM); IDH Wildtype Glioblastoma	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2026-11-10	EARLY_PHASE1
NCT06072781	RECRUITING	Low Grade Serous Ovarian Cancer	Verastem, Inc.	2024-03-18	PHASE3
NCT07318324	RECRUITING	Phase IB; Avutometinib; RAS Pathway; Endometrial	M.D. Anderson Cancer Center	2026-05-13	PHASE1
NCT06194929	RECRUITING	Cutaneous Melanoma; Brain Metastases	University of Utah	2024-03-20	PHASE1; PHASE2
NCT05512208	RECRUITING	Endometrioid Cancer; Mucinous Ovarian Cancer; High Grade Serous Ovarian Cancer; Cervical Cancer; Solid Tumor	University of Oklahoma	2023-02-06	PHASE2
NCT06007924	RECRUITING	Thyroid Cancer	Memorial Sloan Kettering Cancer Center	2023-08-16	PHASE2
NCT07747506	NOT_YET_RECRUITING	Low Grade Ovarian Serous Adenocarcinoma; Ovarian Cancer	Verastem, Inc.	2026-08-03	PHASE2
NCT06394804	RECRUITING	Low-Grade Serous Ovarian Cancer	Memorial Sloan Kettering Cancer Center	2024-04-29	PHASE2
NCT05787561	RECRUITING	Mesonephric Gynecologic Cancer	Memorial Sloan Kettering Cancer Center	2023-03-15	PHASE2
NCT02465060	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma	National Cancer Institute (NCI)	2015-08-17	PHASE2
NCT05798507	ACTIVE_NOT_RECRUITING	Glioblastoma; Recurrent Glioblastoma	Emory University	2023-07-28	EARLY_PHASE1
NCT05669482	ACTIVE_NOT_RECRUITING	KRAS Activating Mutation; Metastatic Cancer; Pancreas Cancer; Neoplasms Pancreatic; Malignant Neoplasm of Pancreas	Verastem, Inc.	2023-03-22	PHASE1; PHASE2
NCT05636514	RECRUITING	Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia; Acute Myeloid Leukemia	Clinical Hub for Interventional Research (CHOIR)	2022-12-14	PHASE1
NCT05074810	ACTIVE_NOT_RECRUITING	Non Small Cell Lung Cancer; KRAS Activating Mutation	Verastem, Inc.	2022-04-12	PHASE1; PHASE2
NCT04331041	ACTIVE_NOT_RECRUITING	Pancreas Cancer; Cancer of the Pancreas; Pancreas Adenocarcinoma	Washington University School of Medicine	2021-08-24	PHASE2
NCT06682572	ACTIVE_NOT_RECRUITING	Low Grade Serous Ovarian Cancer; Ovarian Cancer	Verastem, Inc.	2024-10-30	PHASE2
NCT03727880	COMPLETED	Resectable Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Ductal Adenocarcinoma	Lei Zheng	2019-06-04	PHASE2
NCT04625270	ACTIVE_NOT_RECRUITING	Low Grade Ovarian Serous Adenocarcinoma; Ovarian Cancer	Verastem, Inc.	2020-12-21	PHASE2
NCT04720417	TERMINATED	Metastatic Uveal Melanoma	Thomas Jefferson University	2021-01-26	PHASE2
NCT04620330	COMPLETED	Non Small Cell Lung Cancer; KRAS Activating Mutation	Verastem, Inc.	2020-12-31	PHASE2
NCT03287271	TERMINATED	Ovarian Cancer	Michael McHale	2018-02-06	PHASE1; PHASE2
NCT03875820	ACTIVE_NOT_RECRUITING	NSCLC; Low Grade Serous Ovarian Cancer; Endometrioid Carcinoma; Pancreatic Cancer	Institute of Cancer Research, United Kingdom	2017-12-12	PHASE1
NCT04201145	WITHDRAWN	Malignant Pleural Mesothelioma	Raphael Bueno, MD	2020-09	PHASE1
NCT04439331	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma	National Cancer Institute (NCI)	2015-11-19	PHASE2
NCT02004028	TERMINATED	Malignant Pleural Mesothelioma	Verastem, Inc.	2013-12-12	PHASE2
NCT02758587	UNKNOWN	Carcinoma, Non-small-cell Lung; Mesothelioma; Pancreatic Neoplasms	NHS Greater Glasgow and Clyde	2017-07-04	PHASE1; PHASE2
NCT02943317	TERMINATED	Epithelial Ovarian Cancer	Verastem, Inc.	2016-10	PHASE1
NCT02546531	COMPLETED	Advanced Solid Tumors; Solid Tumors; Pancreatic Cancer	Washington University School of Medicine	2016-02-03	PHASE1
NCT01951690	COMPLETED	Non Small Cell Lung Cancer; Lung Cancer	Verastem, Inc.	2013-09	PHASE2
NCT01870609	TERMINATED	Malignant Pleural Mesothelioma	Verastem, Inc.	2013-09	PHASE2
NCT02372227	TERMINATED	Relapsed Malignant Mesothelioma	Verastem, Inc.	2015-01	PHASE1
NCT02913716	COMPLETED	Healthy Subjects	Verastem, Inc.	2015-08	PHASE1
NCT01778803	COMPLETED	Ovarian Cancer	Verastem, Inc.	2013-02-26	PHASE1
NCT01943292	COMPLETED	Non Hematologic Cancers	Verastem, Inc.	2013-09-02	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-04)

Check the Defactinib (VS-6063) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Defactinib acts as a selective ATP-competitive inhibitor of focal adhesion kinase (FAK), suppressing FAK autophosphorylation at Tyr397 and disrupting downstream integrin-mediated signal transduction pathways such as Src, PI3K/Akt, and ERK/MAPK. This targeted enzymatic inhibition impairs focal adhesion turnover and cell motility, ultimately blocking tumor cell migration, invasion, and tumor-associated stromal remodeling in advanced lung adenocarcinoma, pancreatic cancer, and other refractory solid tumors currently evaluated in clinical trials.

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>).