Clinical Trials

Numerous clinical trials evaluate the therapeutic utility of infigratinib (BGJ398) across Early Phase 1 through Phase 3 studies. These investigations target FGFR-altered solid tumors, cholangiocarcinoma, gastric cancer, bladder carcinoma, and non-oncology disorders such as achondroplasia and tumor-induced osteomalacia. Sponsored by pharmaceutical firms, academic centers, and federal entities, the research portfolio spans diverse recruitment statuses, including completed, actively recruiting, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07393373 ENROLLING_BY_INVITATION
Hypochondroplasia
QED Therapeutics, a BridgeBio company
 2026-04-23 PHASE2
NCT05145010 ENROLLING_BY_INVITATION
Achondroplasia
QED Therapeutics, a BridgeBio company
 2021-12-06 PHASE2
NCT07169279 RECRUITING
Achondroplasia
QED Therapeutics, a BridgeBio company
 2025-11-19 PHASE2
NCT06926491 RECRUITING
Achondroplasia
Kyowa Kirin Co., Ltd.
 2024-12-01 PHASE3
NCT05514912 WITHDRAWN
Resectable Intrahepatic Cholangiocarcinoma; Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8; Stage I Intrahepatic Cholangiocarcinoma AJCC v8; Stage II Intrahepatic Cholangiocarcinoma AJCC v8; Stage III Intrahepatic Cholangiocarcinoma AJCC v8
Emory University
 2024-03-01 PHASE2
NCT06873035 ENROLLING_BY_INVITATION
Hypochondroplasia
QED Therapeutics, a BridgeBio company
 2025-04-22 PHASE2; PHASE3
NCT02657486 COMPLETED
Bladder Cancer; Non-Muscle-Invasive Urothelial Carcinoma
Memorial Sloan Kettering Cancer Center
 2016-01-06
NCT06164951 COMPLETED
Achondroplasia
QED Therapeutics, a BridgeBio company
 2023-11-10 PHASE3
NCT04265651 COMPLETED
Achondroplasia
QED Therapeutics, a BridgeBio company
 2020-03-10 PHASE2
NCT06206278 TERMINATED
Gastric Cancer; Gastroesophageal Junction Adenocarcinoma
LianBio LLC
 2023-10-19 PHASE2
NCT04228042 TERMINATED
Renal Pelvis and Ureter Urothelial Carcinoma
M.D. Anderson Cancer Center
 2020-07-28 PHASE1; PHASE2
NCT04233567 COMPLETED
Advanced Malignant Solid Neoplasm; Cholangiocarcinoma; Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm
Sameek Roychowdhury
 2020-01-16 PHASE2
NCT05510427 WITHDRAWN
Cholangiocarcinoma; Liver Cancer
M.D. Anderson Cancer Center
 2023-08-07 PHASE1
NCT03773302 TERMINATED
Advanced Cholangiocarcinoma; FGFR2 Gene Mutation
QED Therapeutics, a BridgeBio company
 2019-12-27 PHASE3
NCT04197986 TERMINATED
Upper Tract Urothelial Carcinomas; Urothelial Bladder Cancer
QED Therapeutics, a BridgeBio company
 2020-03-11 PHASE3
NCT04424966 TERMINATED
Glioma; Glioblastoma; GBM
Nader Sanai
 2020-07-21 EARLY_PHASE1
NCT02159066 COMPLETED
Melanoma
Pfizer
 2014-07-23 PHASE2
NCT05019794 UNKNOWN
Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Solid Tumor
LianBio LLC
 2020-05-13 PHASE2
NCT05222165 WITHDRAWN
Advanced Solid Tumor; CNS Tumor; Recurrent WHO Grade II Glioma
Helsinn Healthcare SA
 2021-10-01 PHASE1; PHASE2
NCT04972253 WITHDRAWN
Bladder Transitional Cell Carcinoma; Bladder Cancer; Fibroblast Growth Factor Receptor
Guru P. Sonpavde
 2021-12-23 PHASE1
NCT04504331 TERMINATED
Breast Cancer; HER2-negative Breast Cancer; ER Positive Breast Cancer; PR-Positive Breast Cancer
Jennifer Lee Caswell-Jin
 2020-10-13 PHASE1
NCT02150967 TERMINATED
Advanced Cholangiocarcinoma; FGFR2 Gene Mutation
QED Therapeutics, a BridgeBio company
 2014-07-23 PHASE2
NCT02575508 WITHDRAWN
Colon Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Rectal Adenocarcinoma; Stage III Pancreatic Cancer; Stage IIIA Colon Cancer; Stage IIIA Rectal Cancer; Stage IIIB Colon Cancer; Stage IIIB Rectal Cancer; Stage IIIC Colon Cancer; Stage IIIC Rectal Cancer; Stage IV Pancreatic Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer
Roswell Park Cancer Institute
 PHASE1; PHASE2
NCT03510455 TERMINATED
Tumor-Induced Osteomalacia; Oncogenic Osteomalacia
National Institute of Dental and Craniofacial Research (NIDCR)
 2019-02-27 PHASE2
NCT02257541 COMPLETED
Advanced Gastrointestinal Stromal Tumor (GIST)
Memorial Sloan Kettering Cancer Center
 2014-10-02 PHASE1; PHASE2
NCT02706691 TERMINATED
FGFR Gene Amplification; FGFR1 Gene Amplification; FGFR2 Gene Amplification; FGFR2 Gene Mutation; FGFR3 Gene Mutation; Head and Neck Squamous Cell Carcinoma; Human Papillomavirus Infection; Recurrent Head and Neck Carcinoma; Recurrent Nasopharynx Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma
University of Chicago
 2018-06-01 PHASE2
NCT01697605 COMPLETED
Tumor With Alterations of the FGF-R
Novartis Pharmaceuticals
 2012-10-19 PHASE1
NCT03510455 Terminated
Tumor-Induced Osteomalacia|Oncogenic Osteomalacia
National Institute of Dental and Craniofacial Research (NIDCR)|National Institutes of Health Clinical Center (CC)
 2019-02-27 Phase 2
NCT01004224 COMPLETED
Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3; Squamous Lung Cancer With FGFR1 Amplification; Bladder Cancer With FGFR3 Mutation or Fusion; Advanced Solid Tumors With FGFR1 Amplication; Advanced Solid Tumors With FGFR2 Amplication; Advanced Solid Tumors With FGFR3 Mutation
Novartis Pharmaceuticals
 2009-12-11 PHASE1
NCT01975701 COMPLETED
Recurrent Glioblastoma or Other Glioma Subtypes
Novartis Pharmaceuticals
 2013-12-09 PHASE2
NCT02160041 TERMINATED
Solid Tumor; Hematologic Malignancies
Novartis Pharmaceuticals
 2014-07-24 PHASE2
NCT01928459 COMPLETED
Advanced Solid Tumors; Metastatic Solid Tumors
Novartis Pharmaceuticals
 2013-10 PHASE1
NCT02312804 Withdrawn
Cancer of Cervix|Tumors
The University of Texas Health Science Center at San Antonio
 2015-01 Phase 1
NCT02312804 WITHDRAWN
Cancer of Cervix; Tumors
The University of Texas Health Science Center at San Antonio
 2015-01 PHASE1
NCT02160041 Terminated
Solid Tumor|Hematologic Malignancies
Novartis Pharmaceuticals|Novartis
 2014-07-24 Phase 2
NCT01928459 Completed
Advanced Solid Tumors|Metastatic Solid Tumors
Novartis Pharmaceuticals|Novartis
 2013-10 Phase 1
NCT01004224 Completed
Advanced Solid Tumors With Alterations of FGFR1 2 and or 3|Squamous Lung Cancer With FGFR1 Amplification|Bladder Cancer With FGFR3 Mutation or Fusion|Advanced Solid Tumors With FGFR1 Amplication|Advanced Solid Tumors With FGFR2 Amplication|Advanced Solid Tumors With FGFR3 Mutation
Novartis Pharmaceuticals|Novartis
 2009-12-11 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the BGJ398 (Infigratinib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Infigratinib (BGJ398) potently and selectively binds to fibroblast growth factor receptors 1, 2, and 3, inhibiting receptor autophosphorylation and blocking downstream signal transduction pathways to impair cellular proliferation in FGFR-dependent tumor cells. This target-specific kinase inhibition leads to tumor growth suppression and regression, providing the mechanistic rationale for evaluating infigratinib in clinical trials for FGFR-altered advanced solid tumors, cholangiocarcinoma, and gastric carcinoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.