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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: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02936102 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 154 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (157% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory parameters qualifying and reported as AEs.
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 |
Why NCT02936102 stopped before completion
NCT02936102 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (157% higher).
The record links to 0 conditions, and to 2 interventions - of which PDR001 is the first listed.
NCT02936102 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02936102's enrollment target sits among peer trials
154 356th of 2000 higher than 1,643 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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