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NCT Number: NCT01935453

A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer

The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.

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Key information

Conditions

Melanoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Shijitan Hospital,CMU, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients in advanced stage of malignant tumor diagnosticated by pathologic and cytological analysis.
  • lack of routine effective treatment,failure of routine treatment or relapse
  • age of 18-70,ECOG 0-2 and estimated survival is above 3 months
  • had an interval of above 4 weeks since exposure to chemotherapy or radiotherapy and above 6 weeks since exposure to nitrosoureas or mitomycin C.

Exclusion criteria

  • Serious internal diseases
  • uncontrolled primary and metastatic brain tumor
  • sizes of tumor does not meet the requirement of injection

Treatment and study plan

Recombinant hGM-CSF Herpes Simplex Virus Injection

Biological

Other names: OrienX010

Primary outcomes

  1. Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03

    Time frame: 28 days after the last administration

Secondary outcomes

  1. Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010

    Time frame: 28 days after the last administration

Sponsors and collaborators

Lead sponsor

OrienGene Biotechnology Ltd.

Industry

Collaborators

  • Beijing Bozhiyin T&S Co., Ltd.
  • START Shanghai

Registry information

Official study title

A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus

Important dates

Study start
2012
Primary completion
2014
First posted
Sep 5, 2013
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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