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

NCT04594811 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-08-16

No results posted yet for this 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).

Conditions

  • Gastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC)

Interventions

DRUG

NT-I7

Administered by intramuscular (IM) injection.

DRUG

Nivolumab

Administered by intravenous (IV) injection.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2023-05-26
Completion
2023-05-26
FDA Drug
Yes

Countries

  • United States
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04594811 on ClinicalTrials.gov