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BGJ398 · 4 trials · 10 indications
To assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3 based on PFS6 (PFS rate at 6 months as defined by RANO criteria as assessed by the investigator)
The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or the recommended dose for expansion (RDE). Safety(incidence and nature of DLTs), pharmacokinetic and pharmacodynamic data will guide dose escalation decisioins.
Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD). This will be calculated using an established statistical model, based on incidence of adverse events and serious adverse events, physical examinations, vital signs, electrocardiograms, and laboratory parameters
| Arm | Type | Description |
|---|---|---|
| BGJ398X | EXPERIMENTAL | To estimate anti-tumor efficacy of BGJ398 |
| Metastatic breast cancer | EXPERIMENTAL | Evaluation of safety and efficacy in patients with metastatic breast cancer whose tumors contain mutations to PIK3CA and alterations FGFR 1-3. |
| Solid tumor arm 1 | EXPERIMENTAL | Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA. |
| Solid tumor arm 2 | EXPERIMENTAL | Patients with solid tumors (except for colorectal cancer) whose tumomrs express mutations to PIK3CA and alterations to FGFR 1-3 |
| Dose escalation | EXPERIMENTAL | To determine the MTD or RDE of the combination of BGJ398 with BYL719 in patients with advanced or metastastic solid tumors that express mutations to PIK3CA. |
| BGJ398 | EXPERIMENTAL | Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease. |
| Name | Type | Description |
|---|---|---|
| BGJ398 | DRUG | Capsule for oral use. |
| BYL719 | DRUG | BYL719 will be administered orally once daily on each day of the 28-day cycle. |
Inclusion criteria: 1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time of diagnosis or prior relapse. 2. Written documentation of local or central laboratory determination of amplification or translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mut...
BGJ398 is an investigational oral small molecule being studied in oncology for advanced solid tumors, including tumors with alterations in FGFR1, FGFR2, or FGFR3, and for recurrent glioblastoma or other glioma subtypes. It is being developed by Novartis AG and has been evaluated in biomarker-selected patient populations.
BGJ398 targets fibroblast growth factor receptors, specifically FGFR1, FGFR2, and FGFR3. It is a small molecule designed to inhibit these receptor kinases, which is why the clinical program focuses on tumors carrying FGFR alterations such as amplification, mutation, or fusion.
BGJ398 is being developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored the clinical trials evaluating BGJ398 across solid tumors and glioma subtypes, including studies conducted in the United States, Europe, Asia, and Australia.
BGJ398 is in Phase 1 development overall, though it has also been tested in a Phase 2 study in recurrent glioblastoma. It is investigational and has not been approved by the FDA. The completed trials include Phase 1 dose escalation and Phase 1b combination studies.
BGJ398 has been studied in completed trials including NCT01004224, a Phase 1 dose escalation study in advanced solid malignancies with 208 patients, NCT01928459, a Phase 1b trial of BGJ398 with BYL719 in solid tumors, NCT01697605, a Phase 1 study in Asian patients, and NCT01975701, a Phase 2 study in recurrent glioblastoma.
BGJ398 is also known as infigratinib. Both names refer to the same Novartis investigational FGFR inhibitor, so searches for either name lead to the same clinical program in advanced solid tumors and recurrent glioma subtypes.