Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PBF-509_ · 1 trial · 1 indication
The MTD evaluation will be based on the DLT Evaluable Population which includes all patients enrolled in the dose-escalation portion of the trial, who receive the protocol-assigned treatment with PBF-509 and complete the safety follow-up through the DLT evaluation period, or experience a DLT during the DLT evaluation period.
The MTD evaluation will be based on the DLT Evaluable Population which includes all patients enrolled in the dose-escalation portion of the trial, who receive the protocol-assigned treatment with PDR001 and PBF-509 and complete the safety follow-up through the DLT evaluation period, or experience a DLT during the DLT evaluation period.
| Arm | Type | Description |
|---|---|---|
| PBF-509_80 mg | EXPERIMENTAL | - |
| PBF-509_160 mg | EXPERIMENTAL | - |
| PBF-509_320 mg | EXPERIMENTAL | - |
| PBF-509_640 mg | EXPERIMENTAL | - |
| PBF509_160 mg +PDR001 | EXPERIMENTAL | - |
| PBF509_320 mg+PDR001 | EXPERIMENTAL | - |
| PBF509_640 mg +PDR001 | EXPERIMENTAL | - |
| RP2D (PBF-509+PDR001)_immuno naïve | EXPERIMENTAL | Immunotherapy naïve patients will be treated at the combination RP2D previously determined in the phase Ib, dose escalation portion of the trial. |
| RP2D (PBF-509+PDR001)_immuno treated | EXPERIMENTAL | Patients previously treated with immunotherapy (previous immune checkpoint inhibitors; anti-CTLA-4, anti-PD-1, anti-PD-L1 and/or combinations) will be treated at the combination RP2D previously determined in the phase Ib, dose escalation portion of the trial. |
| Name | Type | Description |
|---|---|---|
| PBF-509_80 mg | DRUG | PBF-509: 80 mg, PO, twice daily (BID) |
| PBF-509_160 mg | DRUG | PBF-509: 160 mg, PO, twice daily (BID) |
| PBF-509_320 mg | DRUG | PBF-509: 320 mg, PO, twice daily (BID) |
| PBF-509_640 mg | DRUG | PBF-509: 640 mg, PO, twice daily (BID) |
| Combo PBF-509 (160 mg) + PDR001 | DRUG | Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally |
| Combo PBF-509 (320 mg) + PDR001 | DRUG | Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally |
| Combo PBF-509 (640 mg) + PDR001 | DRUG | Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally |
| RP2D (PBF-509+PDR001)_immuno naïve | DRUG | Drug 1: PDR001 administered intravenously. Drug 2: PBF509 administered orally |
| Experimental: RP2D (PBF-509+PDR001)_immuno treated | DRUG | Drug 1: PDR001 administered intravenously. Drug 2: PBF509 administered orally |
Inclusion Criteria: 1. Patients must have histologic or cytologic diagnosis of advanced/metastatic NSCLC. For those with mixed histology, there must be a predominant histology. 2. Patients must previously have received at least one prior line of therapy for their disease 3. EGFR mutation with exon ...
PBF-509_ is an investigational small molecule being studied for the treatment of advanced non-small cell lung cancer (NSCLC). It was evaluated in a Phase 1 clinical trial in patients with advanced NSCLC. It is not an approved therapy and remains in clinical development.
PBF-509_ is being developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 study of PBF-509_ in patients with advanced non-small cell lung cancer. The asset is part of the company's oncology pipeline.
PBF-509_ is in Phase 1 development. One Phase 1 trial of PBF-509_ has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.
PBF-509_ was studied in NCT02403193, a Phase 1 trial titled Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC). The completed trial enrolled 92 patients aged 18 years and older in the United States and used a controlled design.
Yes, the Phase 1 trial of PBF-509_ in advanced non-small cell lung cancer was biomarker selected, meaning enrollment was guided by a biomarker. The completed study NCT02403193 enrolled 92 patients and was controlled, though it was not randomized or double blinded.