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NCT04682431 · ClinicalTrials.gov registry record · Phase 1
A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Ikena Oncology.
- Terminated
- Registry status
- Phase 1
- Development phase
- 127
- Enrollment target
NCT04682431: Clinical Trial Phase 1 study, sponsored by Ikena Oncology.
NCT04682431 is a Phase 1 study that was terminated before completion, run by Ikena Oncology. The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04682431, a Phase 1 study, was terminated before completion, sponsored by Ikena Oncology.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 127 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, First-In-Human (FIH), Phase 1a/1b study of PY159 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to Standard Of Care (including Checkpoint Inhibitors, 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 PY159 Single agent dose level 1
- DRUG PY159 Single agent dose level 2
- DRUG PY159 Single agent dose level 3
- DRUG PY159 Single agent dose level 4
- DRUG PY159 Single agent dose level 5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2020-11-10 |
| Est. Completion | 2023-08-31 |
| Phase | Phase 1 |
Why NCT04682431 stopped before completion
NCT04682431 is an interventional study that assigns participants to a tested intervention. The registered 127 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 (112% higher).
The record links to 0 conditions, and to 5 interventions - of which PY159 Single agent dose level 1 is the first listed.
NCT04682431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04682431 about?
NCT04682431 is a clinical study titled "A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors". This is an open-label, multicenter, First-In-Human (FIH), Phase 1a/1b study of PY159 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to Standard Of Care (including Checkpoint Inhibitors, if approved for that indication).
What is the current status of trial NCT04682431?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2020-11-10. Estimated completion is 2023-08-31.
What interventions are being tested in trial NCT04682431?
The interventions under investigation include: PY159 Single agent dose level 1 (DRUG), PY159 Single agent dose level 2 (DRUG), PY159 Single agent dose level 3 (DRUG), PY159 Single agent dose level 4 (DRUG), PY159 Single agent dose level 5 (DRUG).
Who is sponsoring clinical trial NCT04682431?
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 NCT04682431's enrollment target sits among peer trials
127 459th of 2000 higher than 1,540 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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