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NCT04383938 · ClinicalTrials.gov registry record · Phase 1

Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies

A Phase 1 study, sponsored by Aprea Therapeutics.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT04383938: Completed Phase 1 study, sponsored by Aprea Therapeutics.

NCT04383938 is a Phase 1 study that has completed, run by Aprea Therapeutics. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04383938, a Phase 1 study, has completed, sponsored by Aprea Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

A phase 1/2, open-label, study to determine the safety and preliminary efficacy of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.

Primary Outcome

To determine the Frequency of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs) related to APR-246 in combination with pembrolizumab.

Interventions

  • DRUG APR-246 (eprenetapopt) + Pembrolizumab

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2020-06-25
Est. Completion 2022-04-30
Phase Phase 1
Aprea Therapeutics

9 total trials

What the finished NCT04383938 record still lists

NCT04383938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 1 intervention - of which APR-246 (eprenetapopt) + Pembrolizumab is the first listed.

NCT04383938 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04383938 about?

NCT04383938 is a clinical study titled "Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies". A phase 1/2, open-label, study to determine the safety and preliminary efficacy of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.

What is the current status of trial NCT04383938?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2020-06-25. Estimated completion is 2022-04-30.

What interventions are being tested in trial NCT04383938?

The interventions under investigation include: APR-246 (eprenetapopt) + Pembrolizumab (DRUG).

Who is sponsoring clinical trial NCT04383938?

This trial is sponsored by Aprea Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04383938's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 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 NCT04383938, the US trial registry maintained by the National Library of Medicine. NCT04383938 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.