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NCT04332653 · ClinicalTrials.gov registry record · Phase 1

NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by NeoImmuneTech.

Completed
Registry status
Phase 1
Development phase
215
Enrollment target
8
Study locations

NCT04332653 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that has completed, run by NeoImmuneTech. The registered enrollment target is 215 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (67% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT04332653, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, has completed, sponsored by NeoImmuneTech.

COMPLETED
Registry status
Phase 1
Development phase
215 participants
Enrollment target
8
Study locations

Study Summary

The main purposes of Phase 1b of this study are to determine the following in participants with advanced solid tumors: * Safety and tolerability of NT-I7 in combination with pembrolizumab * Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) The main purpose of Phase 2a of this study is to assess the preliminary anti-tumor activity of NT-I7 in combination with pembrolizumab in participants with checkpoint inhibitor (CPI) treated and naïve relapsed and refractory (R/R) tumors. The main purpose of the Biomarker Cohort is to assess a potential correlation between tumor infiltrating lymphocytes (TILs) and clinical benefits in participants with CPI-naïve R/R ovarian cancer (OC).

Conditions Studied

Non-Small Cell Lung Cancer Ovarian Cancer Pancreatic Cancer Triple Negative Breast Cancer Small-cell Lung Cancer Microsatellite Stable Colorectal Cancer Any Advanced Solid Tumors

Interventions

  • DRUG NT-I7
  • DRUG pembrolizumab (KEYTRUDA®)

Study Locations (8)

Texas

  • Mary Crowley Cancer Research - Dallas
  • MD Anderson Cancer Center - Houston

Florida

  • Moffit Cancer Center - Tampa

Michigan

  • Barbara Ann Karmanos Cancer Institute - Detroit

Missouri

  • Washington University School of Medicine in St. Louis - St Louis

North Carolina

  • Duke University Medical Center - Durham

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 215 participants
Start Date 2020-06-10
Est. Completion 2025-01-13
Phase Phase 1

Sponsor

NeoImmuneTech

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04332653

The ClinicalTrials.gov registry entry for NCT04332653 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (67% lower). The listed sponsor is NeoImmuneTech, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which NT-I7 is the first listed.

NCT04332653 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Texas, Florida, Michigan.

Frequently Asked Questions

What is clinical trial NCT04332653 about?

NCT04332653 is a clinical study titled "NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors". The main purposes of Phase 1b of this study are to determine the following in participants with advanced solid tumors: * Safety and tolerability of NT-I7 in combination with pembrolizumab * Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) The main purpose of Phase 2a of this...

What is the current status of trial NCT04332653?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 215 participants. The study started on 2020-06-10. Estimated completion is 2025-01-13.

What conditions does trial NCT04332653 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Triple Negative Breast Cancer, Small-cell Lung Cancer.

What interventions are being tested in trial NCT04332653?

The interventions under investigation include: NT-I7 (DRUG), pembrolizumab (KEYTRUDA®) (DRUG).

Who is sponsoring clinical trial NCT04332653?

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

Where is trial NCT04332653 being conducted?

This trial has 8 study locations across Florida, Michigan, Missouri, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.