Clinical Trials

Numerous clinical trials across early to late phases evaluate the pharmacokinetic, safety, and therapeutic profiles of poziotinib in healthy volunteers and patients with advanced solid tumors, HER2-positive gastric cancer, breast cancer, head and neck neoplasms, and non-small cell lung cancer harboring EGFR or HER2 exon 20 insertion mutations. Sponsored by pharmaceutical entities such as Spectrum Pharmaceuticals and Hanmi Pharmaceutical alongside academic institutions including M.D. Anderson Cancer Center and Yonsei University, these protocols display recruitment statuses ranging from completed to terminated, withdrawn, and suspended.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05378763 SUSPENDED
NSCLC
Spectrum Pharmaceuticals, Inc
 2022-05-12 PHASE3
NCT03066206 TERMINATED
EGFR Exon 20 Mutation; ERBB2 Gene Mutation; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Non-Small Cell Lung Cancer AJCC v7
M.D. Anderson Cancer Center
 2017-03-17 PHASE2
NCT03318939 TERMINATED
NSCLC
Spectrum Pharmaceuticals, Inc
 2017-10-11 PHASE2
NCT03744715 TERMINATED
NSCLC; Breast Cancer
Spectrum Pharmaceuticals, Inc
 2018-10-11 PHASE2
NCT04402008 TERMINATED
NSCLC
Spectrum Pharmaceuticals, Inc
 2020-06-23 PHASE1; PHASE2
NCT05045404 WITHDRAWN
Metastatic Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8
M.D. Anderson Cancer Center
 2021-06-16 PHASE2
NCT04172597 TERMINATED
Breast Cancer; Colorectal Cancer; Solid Tumor; Glioblastome Multiforme
Spectrum Pharmaceuticals, Inc
 2019-12-23 PHASE2
NCT04981704 COMPLETED
Healthy
Spectrum Pharmaceuticals, Inc
 2021-04-08 PHASE1
NCT03770988 UNKNOWN
Inoperable or Recurrent or Metastatic Esophageal Squamous Carcinoma
Yonsei University
 2019-04-01 PHASE2
NCT04436562 COMPLETED
Healthy
Spectrum Pharmaceuticals, Inc
 2020-05-29 PHASE1
NCT04436562 Completed
Healthy
Spectrum Pharmaceuticals Inc
 2020-05-29 Phase 1
NCT04044170 TERMINATED
NSCLC
Hanmi Pharmaceutical Company Limited
 2019-07-30 PHASE2
NCT02659514 COMPLETED
Breast Cancer
Spectrum Pharmaceuticals, Inc
 2016-02-22 PHASE2
NCT03292250 COMPLETED
HNSCC; Head and Neck Neoplasms
Seoul National University Hospital
 2017-09-10 PHASE2
NCT03804515 TERMINATED
Solid Tumor
Spectrum Pharmaceuticals, Inc
 2019-06-25 PHASE1
NCT02544997 COMPLETED
Metastatic Breast Cancer
Samsung Medical Center
 2015-09 PHASE2
NCT03804515 Terminated
Solid Tumor
Spectrum Pharmaceuticals Inc
 2019-06-25 Phase 1
NCT03429101 TERMINATED
Breast Cancer
Spectrum Pharmaceuticals, Inc
 2018-07-13 PHASE1
NCT02979821 COMPLETED
HER2 Gene Mutation; Adenocarcinoma Lung Stage IV
Korean Association for the Study of Targeted Therapy
 2016-10 PHASE2
NCT02418689 COMPLETED
Metastatic Breast Cancer
Hanmi Pharmaceutical Company Limited
 2015-04 PHASE2
NCT01819428 TERMINATED
Adenocarcinoma of Lung Stage IIIB; Adenocarcinoma of Lung Stage IV
National OncoVenture
 2013-03 PHASE2
NCT01746771 COMPLETED
HER-2 Positive Advanced Gastric Cancer
Hanmi Pharmaceutical Company Limited
 2012-11 PHASE1; PHASE2
NCT01718847 COMPLETED
Increased Drug Resistance
National OncoVenture
 2013-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-01)

Check the Poziotinib (NOV120101, HM781-36B) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Poziotinib functions as a potent, irreversible pan-HER inhibitor that selectively targets HER1, HER2, and HER4 receptor tyrosine kinases, thereby blocking downstream oncogenic signaling pathways to induce G1 cell cycle arrest and apoptosis. This targeted inhibition of HER family activity underlies its therapeutic evaluation in clinical trials for patients with HER2-positive gastric cancer, breast cancer, and non-small cell lung carcinoma harboring EGFR or HER2 mutations.

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.