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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 is a Phase 1 study that was terminated before completion, run by NeoImmuneTech. The registered enrollment target is 10 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-01-21 |
| Est. Completion | 2023-05-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04594811
The ClinicalTrials.gov registry entry for NCT04594811 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NeoImmuneTech, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04594811 reports 0 study locations.
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.
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