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NCT04691375 · ClinicalTrials.gov registry record · Phase 1
A Study of PY314 in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Ikena Oncology.
- Terminated
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
NCT04691375: Clinical Trial Phase 1 study, sponsored by Ikena Oncology.
NCT04691375 is a Phase 1 study that was terminated before completion, run by Ikena Oncology. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04691375, a Phase 1 study, was terminated before completion, sponsored by Ikena Oncology.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, first in human, Phase 1a/1b study of PY314 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to standard of care (including pembrolizumab, if approved for that indication).
Primary Outcome
Adverse Events will be summarized by MedDRA system organ class and preferred term. Separate tabulations will be produced for all treatment emergent AEs, treatment related AEs, Serious Adverse Events (SAEs), discontinuations due to AEs, and AEs of at least NCI CTCAE grade 3 severity.
Interventions
- DRUG PY314
- DRUG Combination Therapy: PY314 + Pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2023-09-22 |
| Phase | Phase 1 |
Why NCT04691375 stopped before completion
NCT04691375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 2 interventions - of which PY314 is the first listed.
NCT04691375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04691375 about?
NCT04691375 is a clinical study titled "A Study of PY314 in Subjects With Advanced Solid Tumors". This is an open-label, multicenter, first in human, Phase 1a/1b study of PY314 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to standard of care (including pembrolizumab, if approved for that indication).
What is the current status of trial NCT04691375?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2020-10-29. Estimated completion is 2023-09-22.
What interventions are being tested in trial NCT04691375?
The interventions under investigation include: PY314 (DRUG), Combination Therapy: PY314 + Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT04691375?
This trial is sponsored by Ikena Oncology, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04691375's enrollment target sits among peer trials
86 652nd of 2000 higher than 1,345 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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