Clinical trials: Gene, p53
Solid Tumor, Lymphoma
Safety and Efficacy of p53 Gene Therapy Combined With Immune Checkpoint Inhibitors in Solid Tumors.
This is a single arm Phase 2 study of the combination of adenoviral p53 (Ad-p53) gene therapy administered intra-tumorally with approved immune checkpoint inhibitors in patients with recurrent or metastatic cancers.
- Trial name
- NCT03544723
- Testing
- Ad-p53
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- MultiVir, Inc.
Breast Cancer
Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the p53 gene into the tumor may increase the effectiveness of a chemotherapy drug by making tumor…
- Trial name
- NCT00044993
- Testing
- Ad5CMV-p53 gene, docetaxel, doxorubicin hydrochloride
- Where
- United States
- Sponsor
- Introgen Therapeutics
Relapsed or Refractory Multiple Myeloma
QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma
This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 in patients who have relapsed or refractory multiple myeloma.
- Trial name
- NCT01670994
- Testing
- ALT-801
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Altor BioScience
Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma
A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors
This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of APG-115, an MDM2 inhibitor, either alone or in combination with pembrolizumab, a programmed cell death protein-1 (PD-1) inhibitor…
- Conditions
- Unresectable or Metastatic Melanoma or Advanced Solid Tumors, Melanoma, Uveal Melanoma, P53 Mutation
- Trial name
- NCT03611868
- Testing
- Phase 1b: APG-115+pembrolizumab
- Where
- 21 sites in United States, Australia
- Volunteers
- 230 people
- Sponsor
- Ascentage Pharma Group Inc.
Advanced Head and Neck Cancer
P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer
The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs.
- Trial name
- NCT02429037
- Testing
- rAd-p53, radiation, Cisplatin
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
Transitional Cell Carcinoma of Bladder, Urethra Cancer
A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 in a biochemotherapy regimen either containing cisplatin and gemcitabine or containing gemcitabine alone in patients who…
- Conditions
- Transitional Cell Carcinoma of Bladder, Urethra Cancer, Ureter Cancer, Malignant Tumor of Renal Pelvis
- Trial name
- NCT01326871
- Testing
- Cisplatin, Gemcitabine, ALT-801
- Where
- 16 sites in United States
- Volunteers
- 68 people
- Sponsor
- Altor BioScience
Chronic Lymphocytic Leukemia (CLL)
A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on the quality of life of participants including those with with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL; a type of…
- Trial name
- VENICE II (NCT02980731)
- Testing
- Venetoclax
- Where
- 33 sites in Argentina, Australia and 8 more
- Volunteers
- 210 people
- Sponsor
- AbbVie
Ovarian Epithelial Cancer, Fallopian Tube Cancer
p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
The study objective is to investigate the efficacy and safety of p53 combined with chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer.
- Conditions
- Ovarian Epithelial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- NCT02435186
- Testing
- p53 gene, Cisplatin, Paclitaxel
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
Head and Neck Cancer
Gene Therapy in Treating Patients With Recurrent Head and Neck Cancer
RATIONALE: Inserting the gene for p53 into a person's tumor may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.
- Trial name
- NCT00003257
- Testing
- Ad5CMV-p53 gene
- Where
- 10 sites in United States
- Volunteers
- 39 people
- Sponsor
- Aventis Pharmaceuticals
Metastatic Pancreatic Cancer
Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer
This clinical trial is an open label Phase II study of the combination of intravenously administered SGT-53 and gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer.
- Trial name
- NCT02340117
- Testing
- SGT-53, nab-paclitaxel, Gemcitabine
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- SynerGene Therapeutics, Inc.
Non-muscle Invasive Bladder Cancer
A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing or intolerant), non-muscle invasive bladder…
- Trial name
- NCT01625260
- Testing
- ALT-801, Gemcitabine
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Altor BioScience
Non-small Cell Lung Cancer
Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC).
- Trial name
- rAd-p53 (NCT01574729)
- Testing
- Surgery combined with rAd-p53 gene therapy, Surgery
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
Neoplasms
p53 Gene Therapy for Head and Neck Malignant Tumors in Advanced Stage
This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , with concurrent radiotherapy, or combination with surgery…
- Trial name
- NCT00894153
- Testing
- chemotherapy plus p53, chemotherapy, radiotherapy
- Where
- China
- Volunteers
- 1,200 people
- Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
Malignant Pleural Effusion
Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion
Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin.
- Trial name
- NCT02429726
- Testing
- rAdp53, Cisplatin, rAdp53 plus cisplatin
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
Ovarian Cancer
A Study of Adavosertib (MK-1775) in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone for Participants With Platinum-Sensitive Ovarian Tumors With the P53 Gene Mutation (MK-1775-004)
This is a study of the safety and efficacy of adavosertib in combination with paclitaxel plus carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with the P53 mutation.
- Trial name
- NCT01357161
- Testing
- adavosertib, paclitaxel, carboplatin
- Volunteers
- 136 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Hepatocellular Carcinoma (HCC)
Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma
An open-labeled, randomized, active-controlled phase II study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced…
- Trial name
- NCT02509169
- Testing
- TAE plus P53 gene, TAE
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
Advanced Malignant Thyroid Tumors
rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors
This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or combination with surgery for treatment of…
- Trial name
- NCT00902122
- Testing
- rAd-p53 gene, surgery, p53 gene therapy
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
RECURRENT GLIOBLASTOMA
Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma
This Phase II clinical trial is an open label, single arm, multicenter study of the combination of intravenously administered SGT-53 and oral temozolomide in patients with confirmed glioblastoma who have proven tumor recurrence…
- Trial name
- NCT02340156
- Testing
- SGT-53, Temozolomide
- Where
- 2 sites in United States, Taiwan
- Volunteers
- 1 people
- Sponsor
- SynerGene Therapeutics, Inc.
Progressive Metastatic Malignancies
Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies
This is a Phase 1, open-labeled, non-randomized, multi-center, competitive enrollment and dose-escalation study of ALT-801, the study drug.
- Trial name
- NCT00496860
- Testing
- ALT-801
- Where
- 4 sites in United States
- Volunteers
- 26 people
- Sponsor
- Altor BioScience
HCC, Diabetes
p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC).
- Trial name
- NCT02561546
- Testing
- p53 gene therapy, Trans-catheter embolization
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd