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NCT05061537 · ClinicalTrials.gov registry record · Phase 1
Study of PF-07263689 in Participants With Selected Advanced Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT05061537: Clinical Trial Phase 1 study, sponsored by Pfizer.
NCT05061537 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05061537, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and expansion study intended to evaluate the safety, viral load kinetics and shedding, pharmacodynamic, and anti-tumor activity of PF-07263689, either alone or in combination with sasanlimab (an investigational anti-programmed cell death protein 1 \[PD-1\] antibody), in patients with selected locally advanced or metastatic solid tumors who have exhausted all available standard of care therapies available to them. The study consists of 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and in combination with sasanlimab (Part 1B), followed by Part 2 dose expansion for the combination therapy.
Primary Outcome
DLTs=occurrence of any of following adverse events (AEs) attributable to PF-07263689 in first cycle (cycle=28 days): Hematologic: grade(G)4 neutropenia lasting \>5 days; febrile neutropenia; G3 neutropenia with infection, thrombocytopenia with bleeding; G4 thrombocytopenia. Non-hematologic: any treatment-related G\>=3 toxicity; clinical events consistent with Hy's law; any G3 cytokine release syndrome (CRS) not improving to G\<=2 within 72 hours despite medical management; any G4 CRC; G\>=3 toxi
Interventions
- BIOLOGICAL Sasanlimab
- BIOLOGICAL PF-07263689
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2022-10-14 |
| Phase | Phase 1 |
Why NCT05061537 stopped before completion
NCT05061537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Sasanlimab is the first listed.
NCT05061537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05061537 about?
NCT05061537 is a clinical study titled "Study of PF-07263689 in Participants With Selected Advanced Solid Tumors". This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and expansion study intended to evaluate the safety, viral load kinetics and shedding, pharmacodynamic, and anti-tumor activity of PF-07263689, either alone or in combination with sasanlimab (an investigationa...
What is the current status of trial NCT05061537?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-10-20. Estimated completion is 2022-10-14.
What interventions are being tested in trial NCT05061537?
The interventions under investigation include: Sasanlimab (BIOLOGICAL), PF-07263689 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05061537?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05061537's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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