Clinical Trials

Napabucasin (BBI608) has been evaluated in several clinical trials across Phase I, Phase II, and Phase III, sponsored by entities including Sumitomo Pharma America, the NCIC Clinical Trials Group, and the Australasian Gastro-Intestinal Trials Group. Research focuses primarily on oncology indications—including pancreatic ductal carcinoma, metastatic colorectal cancer, non-small-cell lung cancer, hepatocellular carcinoma, and broader solid neoplasms—alongside ADME characterization in healthy volunteers. Key Phase III studies evaluating metastatic pancreatic adenocarcinoma and non-small-cell lung cancer have reached completed or terminated status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03522649 UNKNOWN
Previously Treated Metastatic Colorectal Cancer
1Globe Health Institute LLC
 2018-04-12 PHASE3
NCT01325441 COMPLETED
Cancer
Sumitomo Pharma America, Inc.
 2011-04 PHASE1; PHASE2
NCT04299880 COMPLETED
Oncology
Sumitomo Pharma America, Inc.
 2020-02-24 PHASE1
NCT03647839 COMPLETED
Colorectal Cancer Metastatic
Australasian Gastro-Intestinal Trials Group
 2018-09-06 PHASE2
NCT02467361 COMPLETED
Cancer
Sumitomo Pharma America, Inc.
 2015-08 PHASE1
NCT02231723 COMPLETED
Metastatic Pancreatic Adenocarcinoma
Sumitomo Pharma America, Inc.
 2014-08 PHASE1
NCT02753127 COMPLETED
Colorectal Cancer
Sumitomo Pharma America, Inc.
 2016-06 PHASE3
NCT02993731 COMPLETED
Carcinoma, Pancreatic Ductal
Sumitomo Pharma America, Inc.
 2016-12 PHASE3
NCT02851004 TERMINATED
Metastatic Colorectal Cancer
Takayuki Yoshino
 2016-10 PHASE1; PHASE2
NCT02432326 COMPLETED
Cancer; Advanced Solid Tumors
Sumitomo Pharma America, Inc.
 2015-04 PHASE1
NCT02279719 COMPLETED
Hepatocellular Carcinoma
Sumitomo Pharma America, Inc.
 2014-12 PHASE1; PHASE2
NCT02024607 COMPLETED
Advanced Gastrointestinal Cancer
Sumitomo Pharma America, Inc.
 2014-01 PHASE1; PHASE2
NCT02352558 COMPLETED
Hematologic Malignancy
Sumitomo Pharma America, Inc.
 2015-05 PHASE1
NCT02315534 COMPLETED
Glioblastoma
Sumitomo Pharma America, Inc.
 2015-03 PHASE1; PHASE2
NCT03525405 COMPLETED
ADME; Healthy
Sumitomo Pharma America, Inc.
 2018-05-18 PHASE1
NCT01776307 COMPLETED
Colorectal Cancer
Sumitomo Pharma America, Inc.
 2012-03 PHASE2
NCT02347917 COMPLETED
Malignant Pleural Mesothelioma; Non-Small Cell Lung Cancer
Sumitomo Pharma Co., Ltd.
 2015-02 PHASE1; PHASE2
NCT03525405 Completed
ADME|Healthy
Sumitomo Pharma America Inc.
 2018-05-18 Phase 1
NCT03416816 Terminated
Neoplasms
Sumitomo Pharma America Inc.|Syneos Health
 2018-05-15 Phase 1
NCT03411122 COMPLETED
Drug-drug Interactions
Sumitomo Pharma America, Inc.
 2017-06-30 PHASE1
NCT02358395 COMPLETED
Hepatocellular Carcinoma
Sumitomo Pharma Co., Ltd.
 2015-02 PHASE1
NCT02178956 COMPLETED
Gastric Cancer; Gastroesophageal Junction Cancer
Sumitomo Pharma America, Inc.
 2014-10 PHASE3
NCT02826161 TERMINATED
Carcinoma, Non-Small-Cell Lung
Sumitomo Pharma America, Inc.
 2016-11 PHASE3
NCT02641873 COMPLETED
Metastatic Colorectal Cancer
Sumitomo Pharma Co., Ltd.
 2015-12 PHASE1
NCT01830621 COMPLETED
Colorectal Carcinoma
NCIC Clinical Trials Group
 2013-05-10 PHASE3
NCT01775423 COMPLETED
Cancer, Advanced Malignancies
Sumitomo Pharma America, Inc.
 2009-03 PHASE1
NCT02279719 Completed
Hepatocellular Carcinoma
Sumitomo Pharma America Inc.
 2014-12 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2019-06-18)

Check the Napabucasin (BBI608) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Napabucasin directly targets STAT3 transcription factor signaling and suppresses cancer cell stemness gene expression, thereby inhibiting self-renewal and driving apoptosis in cancer stem-like cells. This targeted blockade of stemness pathways prevents tumor recurrence and resistance, providing therapeutic rationale for its evaluation in advanced malignancies such as pancreatic ductal carcinoma, colorectal cancer, and non-small-cell lung 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.