NCT05998447 is a Phase 2 clinical trial of GEN-001 in Biliary Tract Cancer, sponsored by Genome & Company.

Who is sponsoring NCT05998447?

NCT05998447 is sponsored by Genome & Company.

What drugs are being tested in NCT05998447?

Interventions in NCT05998447: GEN-001, Pembrolizumab, mFOLFOX.

What condition does NCT05998447 study?

NCT05998447 studies Biliary Tract Cancer.

Is NCT05998447 still recruiting?

NCT05998447 is currently terminated. Last updated 16 December 2025.

Last reviewed 2025-12-16 · How we verify

NCT05998447

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

GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer

Terminated Phase 2 Last updated 16 December 2025

What this trial tests

Phase 2 trial testing GEN-001 in Biliary Tract Cancer in 10 participants. Terminated before completion.

Timeline

18 September 2023

Primary endpoint
26 November 2024

26 November 2024

Quick facts

Lead sponsor	Genome & Company
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	18 September 2023
Primary completion	26 November 2024
Estimated completion	26 November 2024
Sites	6 locations across South Korea

Drugs / interventions tested

GEN-001 — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →
mFOLFOX — full drug profile →

Conditions studied

Biliary Tract Cancer — all drugs for Biliary Tract Cancer →

Sponsor

Genome & Company — full company profile →

Who can join

19 and older, any sex, with Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase II, multicenter, open-label study with a safety run-in to evaluate the safety and efficacy of GEN-001 in combination with pembrolizumab or in combination with pembrolizumab and mFOLFOX for patients with advanced refractory BTC who have progressed after 1 or 2 prior standard therapy and are not candidates for any other standard therapy. The safety run-in phase will be conducted before the main study phase

Publications & conference data

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

Potential mechanisms and targeting strategies of the gut microbiota in antitumor immunity and immunotherapy.
Yin Q, Ni JJ, Ying JE. · · 2024 · cited 5× · PMID 39031507 · DOI 10.1002/iid3.1263
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
Microbial metabolites in tumor metabolic reprogramming and immunotherapy: new insights.
Wang Y, Huang D, Wang R, Yin J, et al · · 2025 · PMID 41278473 · DOI 10.3389/fcimb.2025.1706040

Verify or expand the search:

Other trials of GEN-001

Trials testing the same drug.

NCT05419362 — GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer · Phase 2 · completed
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 Biliary Tract Cancer

Currently open trials in the same condition.

NCT07221253 — A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Bili · Phase 3 · recruiting
NCT06529718 — Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients · Phase 2 · recruiting
NCT07151118 — ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer · recruiting
NCT07142226 — Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC · recruiting
NCT07135544 — A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initial · Phase 2 · recruiting

Other Genome & Company trials

Trials by the same sponsor.

NCT05419362 — GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer · Phase 2 · completed
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 NCT05998447 (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/NCT05998447.

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