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Phase I/Ib Trial of Single Agent PBF-509 and in Combination With PDR001 for Patients With Advanced NSCLC (AdenONCO)
The purpose of this study is to determine the safety, tolerability, feasibility and preliminary efficacy of the administration of PBF-509 (Adenosine A2a receptor antagonist) as single agent or in combination with PDR001 (programmed cell death 1 receptor antibody (PD-1 Ab)) to NSCLC patients.
Details
| Lead sponsor | Palobiofarma SL |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 92 |
| Start date | 2015-10 |
| Completion | 2021-11-24 |
Conditions
- Non-small Cell Lung Cancer (NSCLC)
Interventions
- PBF-509_80 mg
- PBF-509_160 mg
- PBF-509_320 mg
- PBF-509_640 mg
- Combo PBF-509 (160 mg) + PDR001
- Combo PBF-509 (320 mg) + PDR001
- Combo PBF-509 (640 mg) + PDR001
- RP2D (PBF-509+PDR001)_immuno naïve
- Experimental: RP2D (PBF-509+PDR001)_immuno treated
Primary outcomes
- Maximum Tolerated Dose (MTD) of PBF-509 as single agent — 28 days
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. - Maximum Tolerated Dose (MTD) of the combination (PBF-509+PDR001) treatment — 56 days
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.
Countries
United States