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NCT04628780 · ClinicalTrials.gov registry record · Phase 1

Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors

A Phase 1 study, sponsored by Pfizer.

Terminated
Registry status
Phase 1
Development phase
37
Enrollment target

NCT04628780: Clinical Trial Phase 1 study, sponsored by Pfizer.

NCT04628780 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04628780, a Phase 1 study, was terminated before completion, sponsored by Pfizer.

TERMINATED
Registry status
Phase 1
Development phase
37 participants
Enrollment target

Study Summary

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.

Primary Outcome

For the purpose of dose escalation, any of the following adverse events were classified as DLTs: Occur in the first cycle of treatment, or within 28 days after the start of the study treatment; and were at least possibly related to PF-07209960; A participant was classified as DLT evaluable if he/she experienced a DLT or if he/she otherwise in the absence of a DLT received 2 doses of the study intervention during Cycle 1 and had received all scheduled safety assessments during the DLT window. If

Interventions

  • BIOLOGICAL PF-07209960

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2020-12-16
Est. Completion 2023-05-26
Phase Phase 1
Pfizer

1,845 total trials

Why NCT04628780 stopped before completion

NCT04628780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).

The record links to 0 conditions, and to 1 intervention - of which PF-07209960 is the first listed.

NCT04628780 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04628780 about?

NCT04628780 is a clinical study titled "Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors". This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with sele...

What is the current status of trial NCT04628780?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2020-12-16. Estimated completion is 2023-05-26.

What interventions are being tested in trial NCT04628780?

The interventions under investigation include: PF-07209960 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04628780?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04628780's enrollment target sits among peer trials

37 1204th of 2000 higher than 791 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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Source: ClinicalTrials.gov NCT04628780, the US trial registry maintained by the National Library of Medicine. NCT04628780 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.