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NCT02936102 · ClinicalTrials.gov registry record · Phase 1
A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 154
- Enrollment target
NCT02936102 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 154 participants.
The verdict
NCT02936102, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 154 participants
- Enrollment target
Study Summary
The purpose of this "first-in-human" study of FAZ053 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053 administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult patients with advanced solid tumors. By blocking the interaction between Programmed Death Ligand-1 (PD-L1) and its receptors, Programmed Death-1 (PD-1) and B7.1, FAZ053 inhibits the PD-L1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells. This study has been designed as a Phase I, open-label, multi-center study with a dose escalation part of FAZ053 as single agent and in combination with PDR001, followed by a dose expansion part of FAZ053 as single agent. FAZ053 will initially be dosed every three weeks. A less frequent dosing regimen such as every 6 weeks may be evaluated in parallel. A patient may continue treatment with FAZ053 single agent or in combination with PDR001 until the patient experiences unacceptable toxicity, confirmed disease progression per immune related Response Criteria and/or treatment is discontinued at the discretion of the investigator or the patient.
Interventions
- DRUG PDR001
- DRUG FAZ053
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2016-10-20 |
| Est. Completion | 2024-11-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02936102
The ClinicalTrials.gov registry entry for NCT02936102 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PDR001 is the first listed.
NCT02936102 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02936102 about?
NCT02936102 is a clinical study titled "A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.". The purpose of this "first-in-human" study of FAZ053 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053 administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult patients with advanced solid tumor...
What is the current status of trial NCT02936102?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 154 participants. The study started on 2016-10-20. Estimated completion is 2024-11-22.
What interventions are being tested in trial NCT02936102?
The interventions under investigation include: PDR001 (DRUG), FAZ053 (DRUG).
Who is sponsoring clinical trial NCT02936102?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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