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GV1001

DRUG9 trials

Sponsors

Gemvax & Kael Co. Ltd., Pharmexa A/S, Oslo University Hospital, Kael-GemVax Co., Ltd., Samsung Pharmaceutical Co., Ltd.

Conditions

Advanced Unresectable Pancreatic CancerAlzheimer's DiseaseBenign Prostatic Hyperplasia (BPH)Carcinoma, HepatocellularInoperable Stage III Non-small Cell Lung CancerMalignant MelanomaModerate Alzheimer's DiseaseNeuro-Degenerative Disease

Phase 1

Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma
CompletedNCT01247623
Oslo University HospitalMalignant Melanoma
Start: 2005-01-31End: 2012-09-30Updated: 2014-11-05
Evaluation of the Safety, Tolerability and PK Characteristics of GV1001 in Healthy Subjects
CompletedNCT06625710
GemVax & KaelNeuro-Degenerative Disease
Start: 2024-10-08End: 2025-08-25Updated: 2025-11-19

Phase 2

A Phase II, Open-Label Trial Evaluating GV1001 in Advanced Hepatocellular Carcinoma.
CompletedNCT00444782
Pharmexa A/SCarcinoma, Hepatocellular
Start: 2006-11-30End: 2008-04-30Target: 41Updated: 2008-12-18
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH
CompletedNCT02855892
GemVax & KaelBenign Prostatic Hyperplasia (BPH)
Start: 2015-10-31End: 2016-10-31Updated: 2022-03-04
GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD)
WithdrawnNCT03959553
GemVax & KaelModerate Alzheimer's Disease
Start: 2019-09-01End: 2022-02-28Updated: 2022-03-03
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Prospective, 52-Week, Phase 2 Clinical Study to Evaluate the Safety and Efficacy of GV1001 Administered Subcutaneously for the Treatment of Mild to Moderate Alzheimer's Disease
CompletedCTIS2024-511610-20-00
Gemvax & Kael Co. Ltd.Alzheimer's Disease
Start: 2022-11-08End: 2025-04-16Target: 103Updated: 2025-03-26

Phase 3

GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
TerminatedNCT00358566
Pharmexa A/SAdvanced Unresectable Pancreatic Cancer
Start: 2006-06-30End: 2008-08-31Updated: 2008-05-19
Study of the Telomerase Vaccine GV1001 to Treat Patients With Inoperable Stage III Non-small Cell Lung Cancer
NCT01579188
Kael-GemVax Co., Ltd.Inoperable Stage III Non-small Cell Lung Cancer
Start: 2012-05-31End: 2016-05-31Target: 600Updated: 2012-04-19
A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients
NCT02854072
Samsung Pharmaceutical Co., Ltd.Pancreatic Cancer
Start: 2015-11-30End: 2018-05-31Target: 148Updated: 2016-11-22

Related Papers

Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015): an open-label, randomised, Phase 3 trial
British Journal of Cancer2023-10-3022 citations
KG 4/2015: A randomized, controlled, multicenter, open-label phase III clinical trial of GV1001 with gemcitabine/capecitabine in previous untreated, eotaxin-high patients with advanced pancreatic ductal adenocarcinoma.
Journal of Clinical Oncology2021-05-203 citations
Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial.
2021-03-2624 citations
A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma.
2010-05-17159 citations