NCT05419362 is a Phase 2 clinical trial of GEN-001 in Gastric Cancer, sponsored by Genome & Company.

Who is sponsoring NCT05419362?

NCT05419362 is sponsored by Genome & Company.

What drugs are being tested in NCT05419362?

Interventions in NCT05419362: GEN-001, Avelumab.

What condition does NCT05419362 study?

NCT05419362 studies Gastric Cancer, Gastroesophageal Junction Adenocarcinoma.

Is NCT05419362 still recruiting?

NCT05419362 is currently completed. Last updated 16 December 2025.

Last reviewed 2025-12-16 · How we verify

NCT05419362

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

GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer

Completed Phase 2 Last updated 16 December 2025

What this trial tests

Phase 2 trial testing GEN-001 in Gastric Cancer in 42 participants. Completed in 26 August 2024.

Timeline

7 April 2022

Primary endpoint
26 August 2024

26 August 2024

Quick facts

Lead sponsor	Genome & Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	7 April 2022
Primary completion	26 August 2024
Estimated completion	26 August 2024
Sites	5 locations across South Korea

Drugs / interventions tested

GEN-001 — full drug profile →
Avelumab (avelumab) — full drug profile →

Conditions studied

Gastric Cancer — all drugs for Gastric Cancer →
Gastroesophageal Junction Adenocarcinoma — all drugs for Gastroesophageal Junction Adenocarcinoma →

Sponsor

Genome & Company — full company profile →

Who can join

19 and older, any sex, with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase II, multicenter, open-label study to evaluate the antitumor activity, efficacy and safety of GEN-001 in combination with avelumab as a third line (3L) or greater line treatment which is not received the Standard of Care (SOC) for patients with PD-L1 positive advanced GC/Gastroesophageal Junction Adenocarcinoma who are not received cancer immunotherapy regimens as mono or combination therapy.

Publications & conference data

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

Gastric cancer immunosuppressive microenvironment heterogeneity: implications for therapy development.
Yasuda T, Wang YA. · · 2024 · cited 139× · PMID 38600020 · DOI 10.1016/j.trecan.2024.03.008
The human microbiome in clinical translation: from bench to bedside.
Bautista J, Echeverría CE, Maldonado-Noboa I, Ojeda-Mosquera S, et al · · 2025 · cited 11× · PMID 41035896 · DOI 10.3389/fmicb.2025.1632435
Multimodal therapeutic strategies against gastric cancer: from conventional treatments to tumor microenvironment targeting.
Yuan X, Chen C, Pang Y, Wang X, et al · · 2025 · cited 2× · PMID 40977700 · DOI 10.3389/fimmu.2025.1623588
Nutritional strategies in supporting immune checkpoint inhibitor, PI3K inhibitor, and tyrosine kinase inhibitor cancer therapies.
Fuller-Shavel N, Davies EJ, Peleg Hasson S. · · 2025 · PMID 41425618 · DOI 10.3389/fnut.2025.1670598

Verify or expand the search:

Other trials of GEN-001

Trials testing the same drug.

NCT05998447 — GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer · Phase 2 · terminated
NCT05079503 — Gut Microbiome and Its Immune Modulation in Locally Advanced Rectal Cancer · NA · unknown
NCT04601402 — GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed · Phase 1 · completed

Other recruiting trials for Gastric Cancer

Currently open trials in the same condition.

NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting

Other Genome & Company trials

Trials by the same sponsor.

NCT05998447 — GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer · Phase 2 · terminated
NCT04601402 — GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed · Phase 1 · completed

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 NCT05419362 (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 Genome & Company
Last refreshed: 16 December 2025

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/NCT05419362.

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