Clinical Trials

Numerous early-phase clinical trials evaluate Vactosertib (TEW-7197) as monotherapy and in combination with chemotherapeutics or immunotherapies across hematologic malignancies and advanced solid tumors, including gastric, colorectal, esophageal, non-small cell lung cancer, and osteosarcoma. Supported by industry sponsors like MedPacto, Inc., alongside academic institutions such as Yonsei University and Weill Medical College of Cornell University, these protocols range in recruitment status from actively recruiting and completed to suspended or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05400122 SUSPENDED
Colorectal Cancer; Hematologic Malignancy; Rectum Cancer; Acute Myeloid Leukemia; Myelodysplastic Syndromes; Acute Lymphoblastic Leukemia; Chronic Myeloid Leukemia; Chronic Lymphocytic Leukemia; Hodgkin Lymphoma; Non Hodgkin Lymphoma; Myeloproliferative Syndrome; Plasma Cell Myeloma; Gastric Cancer; Esophageal Cancer; Esophagus Cancer; Gastric Cancer, Metastatic; Unresectable Esophageal Cancer; Metastatic Esophageal Cancer
David Wald
 2022-09-09 PHASE1
NCT06044311 SUSPENDED
Adenocarcinoma Esophagus; Locally Advanced Adenocarcinoma; Siewert Type I Adenocarcinoma of Esophagogastric Junction; Siewert Type II Adenocarcinoma of Esophagogastric Junction
Melissa Lumish
 2024-09-30 PHASE2
NCT03844750 TERMINATED
Metastatic Malignant Neoplasm in the Liver; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8
Chloe Atreya, MD, PhD
 2019-07-22 PHASE2
NCT05588648 RECRUITING
Osteosarcoma
MedPacto, Inc.
 2023-05-01 PHASE1; PHASE2
NCT05436990 TERMINATED
Acral Melanoma; Mucosal Melanoma
Yonsei University
 2023-02-09 PHASE2
NCT04515979 TERMINATED
Carcinoma, Non-Small-Cell Lung
MedPacto, Inc.
 2020-12-17 PHASE2
NCT04103645 TERMINATED
Myeloproliferative Neoplasm
Weill Medical College of Cornell University
 2019-11-22 PHASE2
NCT03732274 COMPLETED
Non-Small Cell Lung Cancer Metastatic
MedPacto, Inc.
 2019-02-11 PHASE1; PHASE2
NCT03724851 COMPLETED
Metastatic Colorectal Cancer; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma
MedPacto, Inc.
 2018-12-20 PHASE1; PHASE2
NCT03802084 COMPLETED
Desmoid Tumor
Hyo Song Kim
 2019-04-15 PHASE1; PHASE2
NCT04893252 UNKNOWN
Stomach Neoplasm
Hark Kyun Kim
 2021-06-01 PHASE2
NCT04064190 WITHDRAWN
Urothelial Carcinoma Recurrent; Advanced Urothelial Carcinoma
MedPacto, Inc.
 2019-12-13 PHASE2
NCT04656002 UNKNOWN
Gastric Cancer
Samsung Medical Center
 2022-10 PHASE2
NCT04258072 UNKNOWN
Pancreas Cancer
Samsung Medical Center
 2021-04-19 PHASE1
NCT03666832 UNKNOWN
Metastatic Pancreatic Cancer
Joon Oh Park
 2019-06-17 PHASE1; PHASE2
NCT06219733 WITHDRAWN
Dermoid
MedPacto, Inc.
 2021-06-01 PHASE2
NCT03143985 COMPLETED
Multiple Myeloma
Koen van Besien
 2017-07-21 PHASE1
NCT03698825 COMPLETED
Metastatic Gastric Cancer
MedPacto, Inc.
 2018-08-15 PHASE1; PHASE2
NCT03074006 COMPLETED
Myelodysplastic Syndromes
MedPacto, Inc.
 2018-01-04 PHASE1
NCT03704675 COMPLETED
Healthy Volunteers
MedPacto, Inc.
 2018-08-08 PHASE1
NCT02160106 COMPLETED
Advanced Stage Solid Tumors
MedPacto, Inc.
 2014-07-29 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-14)

Check the Vactosertib (TEW-7197) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vactosertib selectively binds to and inhibits activin receptor-like kinase 4 (ALK4) and ALK5, thereby preventing TGF-β-induced Smad2/3 phosphorylation and interrupting canonical downstream signal transduction. By blocking TGF-β signaling, the compound suppresses epithelial-mesenchymal transition and extracellular matrix remodeling, directly addressing the key drivers of tumor progression and immunosuppression targeted in clinical trials for solid tumors and hematologic malignancies.

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.