NCT04032067 is a Phase 3 clinical trial of GV1001 placebo in Benign Prostatic Hyperplasia (BPH), sponsored by GemVax & Kael.

Who is sponsoring NCT04032067?

NCT04032067 is sponsored by GemVax & Kael.

What drugs are being tested in NCT04032067?

Interventions in NCT04032067: GV1001 placebo, Proscar placebo.

What condition does NCT04032067 study?

NCT04032067 studies Benign Prostatic Hyperplasia (BPH).

Is NCT04032067 still recruiting?

NCT04032067 is currently completed. Last updated 25 August 2022.

Last reviewed 2022-08-25 · How we verify

NCT04032067

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)

Completed Phase 3 Last updated 25 August 2022

What this trial tests

Phase 3 trial testing GV1001 placebo in Benign Prostatic Hyperplasia (BPH) in 423 participants. Completed in 17 March 2022.

Timeline

30 October 2019

Primary endpoint
17 March 2022

17 March 2022

Quick facts

Lead sponsor	GemVax & Kael
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	423
Start date	30 October 2019
Primary completion	17 March 2022
Estimated completion	17 March 2022
Sites	23 locations across South Korea

Drugs / interventions tested

GV1001 placebo — full drug profile →
Proscar placebo — full drug profile →

Conditions studied

Benign Prostatic Hyperplasia (BPH) — all drugs for Benign Prostatic Hyperplasia (BPH) →

Sponsor

GemVax & Kael — full company profile →

Who can join

50 and older, male only, with Benign Prostatic Hyperplasia (BPH). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The current study is being conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered as a treatment for Benign prostate hyperplasia(BPH). The investigational drug, GV1001, was first developed as a cancer vaccine for use as active immunotherapy of cancer forms expressing telomerase (eg, pancreatic cancer, prostate cancer, etc.). Subsequently, it was found that GV1001 showed efficacy in alleviating BPH symptoms during in vivo studies by reducing the size of the prostate gland. Based on the result, the effectiveness of GV1001 as a treatment for BPH has been assessed in experimental animals that are designed to develop BPH. It is considered that GV1001 acts to alleviate BPH and the results obtained from previous phase II study indicate that GV1001 may provide potential beneficial effects in BPH patients. So this study is to verify the efficacy and safety of GV1001 on BPH population, large-scale clinical study than phase II.

Publications & conference data

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

Telomere Dysfunction in Chronic Lymphocytic Leukemia.
Jebaraj BMC, Stilgenbauer S. · · 2020 · cited 20× · PMID 33520723 · DOI 10.3389/fonc.2020.612665
Clinical research progress of telomerase targeted cancer immunotherapy: a literature review.
Wang Y, Zhang X, Chen G, Shao M. · · 2024 · cited 6× · PMID 39145070 · DOI 10.21037/tcr-24-196
Breaking barriers: Smart vaccine platforms for cancer immunomodulation.
Gomari MM, Ghantabpour T, Pourgholam N, Rostami N, et al · · 2025 · cited 5× · PMID 39901621 · DOI 10.1002/cac2.70002

Verify or expand the search:

Other recruiting trials for Benign Prostatic Hyperplasia (BPH)

Currently open trials in the same condition.

NCT07016620 — Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia · recruiting
NCT06817733 — Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging · NA · recruiting
NCT06062875 — Effects of TNF Blockade on Human BPH/LUTS · Phase 2 · recruiting
NCT04266418 — The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults · NA · recruiting
NCT04757116 — Post-Market Study to Assess iTind Safety in Comparison to UroLift · NA · recruiting

Other GemVax & Kael trials

Trials by the same sponsor.

NCT06625710 — Evaluation of the Safety, Tolerability and PK Characteristics of GV1001 in Healthy Subjects · Phase 1 · completed
NCT06235775 — Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011 · Phase 2 · completed
NCT05819658 — GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP) · Phase 2 · completed
NCT05189210 — GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD) · Phase 2 · completed
NCT03959553 — GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD) · Phase 2 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04032067 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GemVax & Kael
Last refreshed: 25 August 2022

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/NCT04032067.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing