recombinant adenoviral human p53 gene
Gene therapyexperimental
Clinical trial activity
35 trials · 21 clinical orgs · 0 marketing orgs
Phase 1
14
Phase 2
21
Phase 3
0
Phase 4
3
Earliest trial started Feb 1, 1996 (NCT00019084)
Timeline
Indications
Approved for
Studied for
- Brain Neoplasms · Phase 1
- Breast Neoplasms · Phase 2
- Breast Neoplasms, Male · Phase 1/Phase 2
- Carcinoma, Hepatocellular · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Ovarian Epithelial · Phase 2
- Colorectal Neoplasms · Phase 2
- Diabetes Mellitus · Phase 2
- Fallopian Tube Neoplasms · Phase 2
- Hamartoma · Phase 2
- Head and Neck Neoplasms · Phase 2
- Kidney Neoplasms · Phase 2
- Liver Neoplasms · Phase 1
- Lung Neoplasms · Phase 2
- Lymphoma · Phase 2
- Melanoma · Phase 2
- Mouth Neoplasms · Phase 1/Phase 2
- Neoplasm Metastasis · Phase 4
- Neoplasms · Phase 4
- Oropharyngeal Neoplasms · Phase 1/Phase 2
- Ovarian Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 2
- Pleural Effusion, Malignant · Phase 2
- Precancerous Conditions · Phase 2
- Small Cell Lung Carcinoma · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Thyroid Neoplasms · Phase 4
- Tongue Neoplasms · Phase 1/Phase 2
- Urinary Bladder Neoplasms · Phase 1
- Uterine Cervical Neoplasms · Phase 2
Mechanism of action
- Cellular tumor antigen p53Supplementation
TP53 supplementation
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Also known as
- ad5cmv-p53 gene
- adenovirus-p53 transduced dendritic cell vaccine
- adenovirus vectored p53 tranfected dedritic cells
- ad-p53
- ad.p53-dc vaccine
- autologous dendritic cell-adenovirus p53 vaccine
- mutant p53 peptide pulsed dendritic cell vaccine
- p53 gene
- p53 gene therapy
- rad-p53
- rad-p53 gene
- rad-p53 gene therapy
- recombinant adenoviral human p53 gene
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07150416 | Phase 2 | Oct 1, 2025 | Guangzhou Medical University, Shenzhen SiBiono GeneTech Co.,Ltd |
| NCT03544723 | Phase 2 | Sep 1, 2018 | MultiVir, Inc. |
| NCT02842125 | Phase 1 | Jun 1, 2016 | MultiVir, Inc., University of Texas at Houston |
| NCT02561546 | Phase 2 | Dec 1, 2015 | Shenzhen SiBiono GeneTech Co.,Ltd |
| NCT02435186 | Phase 2 | Jun 1, 2015 | Shenzhen SiBiono GeneTech Co.,Ltd |
| NCT02429726 | Phase 2 | Jun 1, 2015 | Shenzhen SiBiono GeneTech Co.,Ltd |
| NCT02429037 | Phase 2 | May 1, 2015 | Shenzhen SiBiono GeneTech Co.,Ltd |
| NCT02509169 | Phase 2 | Oct 1, 2014 | Shenzhen SiBiono GeneTech Co.,Ltd |
| NCT02418988 | Phase 2 | Jul 1, 2014 | Shenzhen SiBiono GeneTech Co.,Ltd |
| NCT01302821 | N/A | Jan 1, 2013 | National Cancer Institute (NCI), University of South Florida |
| NCT01574729 | Phase 2 | Aug 1, 2012 | People's Liberation Army of China, Shenzhen SiBiono GeneTech Co.,Ltd |
| NCT01042535 | Phase 1/Phase 2 (Phase 2) | Dec 28, 2009 | National Cancer Institute (NCI), University of South Florida |
| NCT00902083 | Phase 4 | Jun 1, 2009 | Shenzhen SiBiono GeneTech Co.,Ltd, Sichuan University |
| NCT00894153 | Phase 4 | May 1, 2009 | Shenzhen SiBiono GeneTech Co.,Ltd |
| NCT00902122 | Phase 4 | May 1, 2009 | Shenzhen SiBiono GeneTech Co.,Ltd, Sichuan University |
| NCT00704938 | Phase 2 | Jun 1, 2008 | National Cancer Institute (NCI), National Institutes of Health (NIH) |
| NCT00617409 | Phase 2 | Oct 2, 2007 | University of South Florida |
| NCT00776295 | Phase 2 | May 1, 2007 | University of South Florida |
| NCT00404339 | Phase 1 | Sep 1, 2005 | National Cancer Institute (NCI), University of Pittsburgh |
| NCT00082641 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2004 | National Cancer Institute (NCI), University of Nebraska, University of South Florida |
Showing 20 of 35 trials
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Organizations
Research & Development (21)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 17 | 8 | 3 | 1996 |
| Shenzhen SiBiono GeneTech Co.,Ltd | For profit | 11 | 10 | 2 | 2009 |
| University of South Florida | Academic/Hospital | 6 | 5 | 2 | 2003 |
| University of Texas at Houston | Academic/Hospital | 5 | 0 | 2 | 1998 |
| Eastern Cooperative Oncology Group | Academic/Hospital | 2 | 2 | 1 | 1998 |
| MultiVir, Inc. | For profit | 2 | 2 | 2 | 2016 |
| National Institutes of Health (NIH) | Government | 2 | 1 | 1 | 2000 |
| Sichuan University | Academic/Hospital | 2 | 0 | 1 | 2009 |
| University of Pittsburgh | Academic/Hospital | 2 | 1 | 1 | 1998 |
| Aventis | For profit | 1 | 1 | 1 | 1998 |
| Guangzhou Medical University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Introgen Therapeutics | For profit | 1 | 1 | 1 | 2002 |
| People's Liberation Army of China | Government | 1 | 0 | 1 | 2012 |
| Southwest Oncology Group | Academic/Hospital | 1 | 1 | 1 | 2003 |
| Temple University | Academic/Hospital | 1 | 0 | 1 | 1999 |
| The University of Texas, Dallas | Academic/Hospital | 1 | 1 | 1 | 1998 |
| University of Nebraska | Academic/Hospital | 1 | 1 | 1 | 2004 |
| University of New Mexico | Academic/Hospital | 1 | 0 | 1 | 1998 |
| University of Wisconsin | Academic/Hospital | 1 | 0 | 1 | 2000 |
| Vanderbilt University | Academic/Hospital | 1 | 0 | 1 | 1998 |
21 organizations
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