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NCT04234113 · ClinicalTrials.gov registry record · Phase 1
Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study, sponsored by SOTIO Biotech.
- Terminated
- Registry status
- Phase 1
- Development phase
- 115
- Enrollment target
NCT04234113: Clinical Trial Phase 1 study, sponsored by SOTIO Biotech.
NCT04234113 is a Phase 1 study that was terminated before completion, run by SOTIO Biotech. The registered enrollment target is 115 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04234113, a Phase 1 study, was terminated before completion, sponsored by SOTIO Biotech.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 115 participants
- Enrollment target
Study Summary
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
Primary Outcome
* Grade (gr) 5 not related to disease progression or other causes * Gr ≥3 non-hematologic toxicity; exceptions: gr 3 nausea, vomiting or diarrhea controlled in 72 hours; gr 3 fatigue \<5 days; gr ≥3 correctable electrolyte abnormalities \<72 hours and no clinical complications; gr ≥3 amylase or lipase without clinical pancreatitis * Hy's law cases * Gr 3 AST or ALT or gr 3 bilirubinemia \>5 days * Hematologic DLTs: gr 4 neutropenia or thrombocytopenia \>7 days, febrile neutropenia, gr ≥3 thrombo
Interventions
- DRUG Pembrolizumab
- DRUG Nanrilkefusp alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2024-11-27 |
| Phase | Phase 1 |
Why NCT04234113 stopped before completion
NCT04234113 is an interventional study that assigns participants to a tested intervention. The registered 115 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 (92% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04234113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04234113 about?
NCT04234113 is a clinical study titled "Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors". A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
What is the current status of trial NCT04234113?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2019-06-13. Estimated completion is 2024-11-27.
What interventions are being tested in trial NCT04234113?
The interventions under investigation include: Pembrolizumab (DRUG), Nanrilkefusp alfa (DRUG).
Who is sponsoring clinical trial NCT04234113?
This trial is sponsored by SOTIO Biotech, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04234113's enrollment target sits among peer trials
115 504th of 2000 higher than 1,494 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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