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NCT02079324: GX-051

A Single Center, Open-Label, Accelerated Titration, Dose-Escalating, Phase Ι Study to Evaluate the Safety and Tolerability of IT Injection GX-051, Stem Cell Based Gene Therapeutics in Patients With Very Advanced Head and Neck Cancer

Completed Phase 1 Last updated 18 August 2025
What this trial tests

Phase 1 trial testing GX-051 in Head and Neck Cancer in 12 participants. Completed in 1 September 2016.

Timeline
1 March 2014
Primary endpoint
1 September 2016
1 September 2016

Quick facts

Lead sponsorGenexine, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment12
Start date1 March 2014
Primary completion1 September 2016
Estimated completion1 September 2016
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Genexine, Inc. — full company profile →

Who can join

19 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after intratumoral injection in head and neck cancer patience.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Stromal cells in the tumor microenvironment: accomplices of tumor progression?
    Zhao Y, Shen M, Wu L, Yang H, et al · · 2023 · cited 271× · PMID 37666813 · DOI 10.1038/s41419-023-06110-6
  2. Mesenchymal stem/stromal cells in cancer therapy.
    Lan T, Luo M, Wei X. · · 2021 · cited 251× · PMID 34789315 · DOI 10.1186/s13045-021-01208-w
  3. Therapeutic Potential of Mesenchymal Stem Cells for Cancer Therapy.
    Hmadcha A, Martin-Montalvo A, Gauthier BR, Soria B, et al · · 2020 · cited 241× · PMID 32117924 · DOI 10.3389/fbioe.2020.00043
  4. Targeting the tumor stroma for cancer therapy.
    Xu M, Zhang T, Xia R, Wei Y, et al · · 2022 · cited 195× · PMID 36324128 · DOI 10.1186/s12943-022-01670-1
  5. Stem cell-based therapies for cancer treatment: separating hope from hype.
    Stuckey DW, Shah K. · · 2014 · cited 171× · PMID 25176333 · DOI 10.1038/nrc3798
  6. The Current Status of Mesenchymal Stromal Cells: Controversies, Unresolved Issues and Some Promising Solutions to Improve Their Therapeutic Efficacy.
    García-Bernal D, García-Arranz M, Yáñez RM, Hervás-Salcedo R, et al · · 2021 · cited 94× · PMID 33796536 · DOI 10.3389/fcell.2021.650664
  7. Genetic Engineering as a Strategy to Improve the Therapeutic Efficacy of Mesenchymal Stem/Stromal Cells in Regenerative Medicine.
    Damasceno PKF, de Santana TA, Santos GC, Orge ID, et al · · 2020 · cited 78× · PMID 32974331 · DOI 10.3389/fcell.2020.00737
  8. Inflammatory Mediators in Glioma Microenvironment Play a Dual Role in Gliomagenesis and Mesenchymal Stem Cell Homing: Implication for Cellular Therapy.
    Al-Kharboosh R, ReFaey K, Lara-Velazquez M, Grewal SS, et al · · 2020 · cited 60× · PMID 32793872 · DOI 10.1016/j.mayocpiqo.2020.04.006

Verify or expand the search:

Other recruiting trials for Head and Neck Cancer

Currently open trials in the same condition.

Other Genexine, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02079324.

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