NCT05019794 (FGFR) is a Phase 2 clinical trial of Infigratinib in Gastric Cancer, sponsored by LianBio LLC.

Who is sponsoring NCT05019794?

NCT05019794 is sponsored by LianBio LLC.

What drugs are being tested in NCT05019794?

Interventions in NCT05019794: Infigratinib.

What condition does NCT05019794 study?

NCT05019794 studies Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Solid Tumor.

Is NCT05019794 still recruiting?

NCT05019794 is currently status unknown. Last updated 27 June 2022.

Last reviewed 2022-06-27 · How we verify

NCT05019794: FGFR

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

Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations

Status unknown Phase 2 Last updated 27 June 2022

What this trial tests

Phase 2 trial testing Infigratinib in Gastric Cancer in 80 participants. Status unknown.

Timeline

13 May 2020

Primary endpoint
30 December 2022

30 December 2023

Quick facts

Lead sponsor	LianBio LLC
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	13 May 2020
Primary completion	30 December 2022
Estimated completion	30 December 2023
Sites	17 locations across China

Drugs / interventions tested

Infigratinib (INFIGRATINIB) — full drug profile →

Conditions studied

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

Sponsor

LianBio LLC

Who can join

Adults 18 to 75, any sex, with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 1-3. This is a multicenter, open-label, single arm phase IIa study to evaluate the efficacy and safety of Infigratinib in subjects with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 genetic amplification or other advanced solid tumors with other FGFR genetic alternations who have failed in 2nd line or above treatment. This trial includes 2 cohorts (i.e., baskets) with above mentioned indications.

Publications & conference data

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

Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
Biological Significance and Targeting of the FGFR Axis in Cancer.
Chioni AM, Grose RP. · · 2021 · cited 45× · PMID 34830836 · DOI 10.3390/cancers13225681
The HIF-1α as a Potent Inducer of the Hallmarks in Gastric Cancer.
Ucaryilmaz Metin C, Ozcan G. · · 2022 · cited 33× · PMID 35681691 · DOI 10.3390/cancers14112711
Targeting FGFR2 Positive Gastroesophageal Cancer: Current and Clinical Developments.
Gordon A, Johnston E, Lau DK, Starling N. · · 2022 · cited 25× · PMID 36238135 · DOI 10.2147/ott.s282718
FGFR Pathway Inhibition in Gastric Cancer: The Golden Era of an Old Target?
Lengyel CG, Hussain S, Seeber A, Jamil Nidhamalddin S, et al · · 2022 · cited 18× · PMID 35054474 · DOI 10.3390/life12010081
Diffuse Gastric Cancer: A Comprehensive Review of Molecular Features and Emerging Therapeutics.
Wu LW, Jang SJ, Shapiro C, Fazlollahi L, et al · · 2024 · cited 13× · PMID 39271577 · DOI 10.1007/s11523-024-01097-2
Clinical Developments and Challenges in Treating FGFR2-Driven Gastric Cancer.
Lau DK, Collin JP, Mariadason JM. · · 2024 · cited 11× · PMID 38791079 · DOI 10.3390/biomedicines12051117
Unveiling promising targets in gastric cancer therapy: A comprehensive review.
Li W, Wei J, Cheng M, Liu M. · · 2024 · cited 10× · PMID 39280587 · DOI 10.1016/j.omton.2024.200857

Verify or expand the search:

Other trials of Infigratinib

Trials testing the same drug.

NCT07393373 — Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia · Phase 2 · enrolling by invitation
NCT06206278 — Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma · Phase 2 · terminated
NCT05510427 — Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advance · Phase 1 · withdrawn
NCT05145010 — Extension Study of Infigratinib in Children With Achondroplasia (ACH) · Phase 2 · enrolling by invitation
NCT05222165 — Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With · Phase 1, PHASE2 · withdrawn

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 LianBio LLC trials

Trials by the same sponsor.

NCT06206278 — Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma · Phase 2 · terminated
NCT06032936 — BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations · Phase 1 · terminated
NCT05629390 — Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study · Phase 3 · completed
NCT05621525 — Phase I Study of the BBP-398 in Patients With Advance Solid Tumors · Phase 1 · terminated
NCT05174416 — A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM · Phase 3 · 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 NCT05019794 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 LianBio LLC
Last refreshed: 27 June 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/NCT05019794.

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