NCT03425773: BVAC-B

Safety and Tolerability Evaluation Study of BVAC-B in Patients With HER2/Neu(Human Epithelial Growth Factor Receptor 2) Positive Gastric Cancer After Failure to Standard Care

Completed Phase 1 Last updated 20 February 2020

What this trial tests

Phase 1 trial testing BVAC-B in Stomach Neoplasms in 8 participants. Completed in 13 May 2019.

Timeline

26 February 2018

Primary endpoint
13 May 2019

13 May 2019

Quick facts

Lead sponsor	Cellid Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	26 February 2018
Primary completion	13 May 2019
Estimated completion	13 May 2019
Sites	1 location across South Korea

Drugs / interventions tested

• BVAC-B — full drug profile →

Conditions studied

• Stomach Neoplasms — all drugs for Stomach Neoplasms →

Sponsor

Cellid Co., Ltd. — full company profile →

Who can join

19 and older, any sex, with Stomach Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

BVAC-B is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell. This study is Open-label, Accelerated titration, Multiple dosing study to evaluate the safety, tolerability, immune response and pre-efficacy of BVAC-B in patients with progressive or recurrent HER2/neu positive gastric cancer after failure to standard care. 9-27 patients will be enrolled.

Publications & conference data

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

1. Colorectal cancer vaccines: Tumor-associated antigens <i>vs</i> neoantigens.
   Wagner S, Mullins CS, Linnebacher M. · · 2018 · cited 106× · PMID 30622371 · DOI 10.3748/wjg.v24.i48.5418
2. HER2-Directed Therapy in Advanced Gastric and Gastroesophageal Adenocarcinoma: Triumphs and Troubles.
   Grieb BC, Agarwal R. · · 2021 · cited 20× · PMID 34424404 · DOI 10.1007/s11864-021-00884-7
3. Targeting of promising transmembrane proteins for diagnosis and treatment of pancreatic ductal adenocarcinoma.
   Mashayekhi V, Mocellin O, Fens MHAM, Krijger GC, et al · · 2021 · cited 16× · PMID 34522225 · DOI 10.7150/thno.60350
4. First-in-Human Phase 1 Study of a B Cell- and Monocyte-Based Immunotherapeutic Vaccine against HER2-Positive Advanced Gastric Cancer.
   Jung M, Lee JB, Kim HS, Kwon WS, et al · · 2024 · cited 10× · PMID 37402409 · DOI 10.4143/crt.2022.1328
5. Cancer Vaccines: From the State of the Art to the Most Promising Frontiers in the Treatment of Colorectal Cancer.
   Martinis E, Ricci C, Trevisan C, Tomadini G, et al · · 2023 · cited 5× · PMID 37514155 · DOI 10.3390/pharmaceutics15071969
6. From Interconnection between Genes and Microenvironment to Novel Immunotherapeutic Approaches in Upper Gastro-Intestinal Cancers-A Multidisciplinary Perspective.
   Accordino G, Lettieri S, Bortolotto C, Benvenuti S, et al · · 2020 · cited 4× · PMID 32751137 · DOI 10.3390/cancers12082105
7. Targeted and Immunotherapy Approaches in HER2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma: A New Era.
   Radford M, Abushukair H, Hentzen S, Cavalcante L, et al · · 2023 · cited 3× · PMID 37637236 · DOI 10.36401/jipo-22-36
8. Clinical Applications of Combined Immunotherapy Approaches in Gastrointestinal Cancer: A Case-Based Review.
   Eralp Y, Ates U. · · 2023 · cited 2× · PMID 37896948 · DOI 10.3390/vaccines11101545