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NCT04121442 · ClinicalTrials.gov registry record · Phase 1
Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors
A Phase 1 study, sponsored by Buzzard Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT04121442: Completed Phase 1 study, sponsored by Buzzard Pharmaceuticals.
NCT04121442 is a Phase 1 study that has completed, run by Buzzard Pharmaceuticals. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04121442, a Phase 1 study, has completed, sponsored by Buzzard Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Isunakinra - a potent Interleukin-1 receptor inhibitor - will be given to patients with solid tumors to determine safety and tolerability of three different doses. Isunakinra will then be combined with a PD-(L)1 inhibitor. Pharmacokinetics and Pharmacodynamic effects of monotherapy treatment as well as the combination will be evaluated.
Primary Outcome
The primary endpoint of this study is the proportion of patients who experience DLTs. The MTD (Maximum Tolerated Dose) will be determined based on the dose escalation cohorts. The evaluation period for DLTs will be 21 days following the first dose of Isunakinra and 28 days following addition of PD1-PDL1 inhibitor
Interventions
- BIOLOGICAL Isunakinra
- BIOLOGICAL PD-(L)1 Inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2024-07-15 |
| Phase | Phase 1 |
What the finished NCT04121442 record still lists
NCT04121442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Isunakinra is the first listed.
NCT04121442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04121442 about?
NCT04121442 is a clinical study titled "Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors". Isunakinra - a potent Interleukin-1 receptor inhibitor - will be given to patients with solid tumors to determine safety and tolerability of three different doses. Isunakinra will then be combined with a PD-(L)1 inhibitor. Pharmacokinetics and Pharmacodynamic effects of monotherapy treatment as well...
What is the current status of trial NCT04121442?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2020-09-01. Estimated completion is 2024-07-15.
What interventions are being tested in trial NCT04121442?
The interventions under investigation include: Isunakinra (BIOLOGICAL), PD-(L)1 Inhibitor (BIOLOGICAL).
Who is sponsoring clinical trial NCT04121442?
This trial is sponsored by Buzzard Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04121442's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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