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NCT04594811 · ClinicalTrials.gov registry record · Phase 1

NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma

A Phase 1 study, sponsored by NeoImmuneTech.

Terminated
Registry status
Phase 1
Development phase
10
Enrollment target

NCT04594811: Clinical Trial Phase 1 study, sponsored by NeoImmuneTech.

NCT04594811 is a Phase 1 study that was terminated before completion, run by NeoImmuneTech. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04594811, a Phase 1 study, was terminated before completion, sponsored by NeoImmuneTech.

TERMINATED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

The main purposes of the dose escalation part of this study is to determine the following in participants with gastric or gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC): * Safety and tolerability of NT-I7 in combination with nivolumab * Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) The main purposes of Phase 2 of this study is to make a preliminary assessment of the antitumor activity and long-term survival of NT-I7 in combination with nivolumab in participants with gastric or GEJ or EAC. Note, this trial was intended to be a Phase 1/2 trial (but the trial never moved forward to Phase 2).

Interventions

  • DRUG Nivolumab
  • DRUG NT-I7

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2021-01-21
Est. Completion 2023-05-26
Phase Phase 1
NeoImmuneTech

6 total trials

Why NCT04594811 stopped before completion

NCT04594811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.

NCT04594811 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04594811 about?

NCT04594811 is a clinical study titled "NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma". The main purposes of the dose escalation part of this study is to determine the following in participants with gastric or gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC): * Safety and tolerability of NT-I7 in combination with nivolumab * Maximum Tolerated Dose (MTD) and/or the R...

What is the current status of trial NCT04594811?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-01-21. Estimated completion is 2023-05-26.

What interventions are being tested in trial NCT04594811?

The interventions under investigation include: Nivolumab (DRUG), NT-I7 (DRUG).

Who is sponsoring clinical trial NCT04594811?

This trial is sponsored by NeoImmuneTech, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04594811's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 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 NCT04594811, the US trial registry maintained by the National Library of Medicine. NCT04594811 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.