10 completed, 10 terminated, 6 withdrawn, 3 enrolling by invitation. 19 Phase 2, 11 Phase 1, 4 Phase 3, 1 Early Phase 1, 1 Not applicable.
Follow infigratinib: new trials by email Literature Review of infigratinib trials Research Report on infigratinib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia Infigratinib - Hypochondroplasia | Phase 2 | Enrolling by invitation | QED Therapeutics, a BridgeBio company | 135 | 2026-04-23 | 2026-08-26 |
| Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH) Infigratinib is provided as a single dose of minitablets for oral administration, Infigratinib is provided as sprinkle capsules for daily oral administration, Infigratinib or placebo comparator is provided as sprinkle capsules for daily oral administration - Achondroplasia | Phase 2 | Recruiting | QED Therapeutics, a BridgeBio company | 77 | 2025-11-19 | 2026-07-13 |
| An Interventional Study of Infigratinib in Children With Hypochondroplasia infigratinib 0.128 mg/kg/day, infigratinib 0.25 mg/kg/day - Hypochondroplasia | Phase 2 / Phase 3 | Enrolling by invitation | QED Therapeutics, a BridgeBio company | 24 | 2025-04-22 | 2026-07-16 |
| Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial Cisplatin, Gemcitabine Hydrochloride, Infigratinib Phosphate - Resectable Intrahepatic Cholangiocarcinoma, Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8 | Phase 2 | Withdrawn | Emory University | 2024-03-01 | 2023-12-26 | |
| A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia Infigratinib 0.25 mg/kg/day, Placebo Comparator 0.25 mg/kg/day - Achondroplasia | Phase 3 | Completed | QED Therapeutics, a BridgeBio company | 114 | 2023-11-10 | 2026-03-17 |
| Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma Infigratinib - Gastric Cancer, Gastroesophageal Junction Adenocarcinoma | Phase 2 | Terminated | LianBio LLC | 6 | 2023-10-19 | 2024-08-14 |
| Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification Infigratinib, Atezolizumab, Bevacizumab - Cholangiocarcinoma, Liver Cancer | Phase 1 | Withdrawn | M.D. Anderson Cancer Center | 2023-08-07 | 2023-08-15 | |
| Phase I BLASST-3 Trial Infigratinib - Bladder Transitional Cell Carcinoma, Bladder Cancer | Phase 1 | Withdrawn | Guru P. Sonpavde | 2021-12-23 | 2022-08-10 | |
| Extension Study of Infigratinib in Children With Achondroplasia (ACH) Infigratinib - Achondroplasia | Phase 2 | Enrolling by invitation | QED Therapeutics, a BridgeBio company | 300 | 2021-12-06 | 2025-10-31 |
| Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations Infigratinib - Advanced Solid Tumor, CNS Tumor | Phase 1 / Phase 2 | Withdrawn | Helsinn Healthcare SA | 2021-10-01 | 2023-02-23 | |
| Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer Infigratinib, Tamoxifen, Omnipaque 350 - Breast Cancer, HER2-negative Breast Cancer | Phase 1 | Terminated | Jennifer Lee Caswell-Jin | 4 | 2020-10-13 | 2026-02-12 |
| Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer Infigratinib, Quality-of-Life Assessment, Questionnaire Administration - Renal Pelvis and Ureter Urothelial Carcinoma | Phase 1 / Phase 2 | Terminated | M.D. Anderson Cancer Center | 15 | 2020-07-28 | 2025-01-01 |
| Infigratinib in Recurrent High-Grade Glioma Patients Infigratinib - Glioma, Glioblastoma | Early Phase 1 | Terminated | Nader Sanai | 7 | 2020-07-21 | 2025-10-24 |
| Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations Infigratinib - Gastric Cancer, Gastroesophageal Junction Adenocarcinoma | Phase 2 | Unknown | LianBio LLC | 80 | 2020-05-13 | 2022-06-27 |
| Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations Infigratinib, Placebo - Upper Tract Urothelial Carcinomas, Urothelial Bladder Cancer | Phase 3 | Terminated | QED Therapeutics, a BridgeBio company | 39 | 2020-03-11 | 2024-03-13 |
| Study of Infigratinib in Children With Achondroplasia Infigratinib 0.016 mg/kg, Infigratinib 0.032 mg/kg, Infigratinib 0.064 mg/kg - Achondroplasia | Phase 2 | Completed | QED Therapeutics, a BridgeBio company | 84 | 2020-03-10 | 2025-10-22 |
| Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Infigratinib - Advanced Malignant Solid Neoplasm, Cholangiocarcinoma | Phase 2 | Completed | Sameek Roychowdhury | 17 | 2020-01-16 | 2026-02-24 |
| Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations BGJ398, Gemcitabine, Cisplatin - Advanced Cholangiocarcinoma, FGFR2 Gene Mutation | Phase 3 | Terminated | QED Therapeutics, a BridgeBio company | 48 | 2019-12-27 | 2024-05-08 |
| BGJ398 for the Treatment of Tumor-Induced Osteomalacia BGJ398 - Tumor-Induced Osteomalacia, Oncogenic Osteomalacia | Phase 2 | Terminated | National Institute of Dental and Craniofacial Research (NIDCR) | 4 | 2019-02-27 | 2021-04-08 |
| BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer BGJ398 - FGFR Gene Amplification, FGFR1 Gene Amplification | Phase 2 | Terminated | University of Chicago | 1 | 2018-06-01 | 2019-04-16 |
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Bone Diseases (6) · Mucopolysaccharidosis IV (6) · Musculoskeletal Diseases (6) · Osteochondrodysplasias (6) · Cholangiocarcinoma (5) · Dwarfism (5) · Genetic Diseases, Inborn (5) · Achondroplasia (4) · Acrocephalosyndactylia (3) · Urinary Bladder Neoplasms (3) · Breast Neoplasms (2) · Glioblastoma (2) · Hypochondroplasia (2) · Stomach Neoplasms (2) · Bone Diseases, Developmental (1)
QED Therapeutics, a BridgeBio company (9) · Novartis Pharmaceuticals (5) · LianBio LLC (2) · M.D. Anderson Cancer Center (2) · Memorial Sloan Kettering Cancer Center (2) · Emory University (1) · Guru P. Sonpavde (1) · Helsinn Healthcare SA (1) · Jennifer Lee Caswell-Jin (1) · Nader Sanai (1) · National Institute of Dental and Craniofacial Research (NIDCR) (1) · Pfizer (1) · Roswell Park Cancer Institute (1) · Sameek Roychowdhury (1) · The University of Texas Health Science Center at San Antonio (1)
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David van Veenhuyzen, M.B., Ch.B., M.Pharm.Med. (1) · Guru Sonpavde, MD (1) · Jennifer Lee Caswell-Jin (1) · Jonathan Rosenberg, MD (1) · Mehrad Adibi, MD (1) · Qiao Sun, Doctor (1) · Rachel I Gafni, M.D. (1) · Sameek Roychowdhury, M.D. (1)
PMID 25763789, PMID 29182496, PMID 30101387, PMID 32580579, PMID 34358484, PMID 34376578, PMID 35342457, PMID 35608106, PMID 36058810, PMID 38573872, PMID 39555818, PMID 41914670, PMID 42337043, PMID 42370681
2009 (1), 2018 (1), 2019 (1), K08CA252457 (1), P30CA016056 (1), P30CA138292 (1)