Trials / Terminated
TerminatedNCT04594811
NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma
A Multicenter, Open-label, Phase 1 Dose Escalation ,Phase 2 Study of NT-I7 in Combination With Nivolumab in Subjects With Relapsed/Refractory Gastric or Gastro-Esophageal Junction or Esophageal Adenocarcinoma Who Progressed on or Intolerant to 2 or More Prior Lines of Systemic Therapy
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- NeoImmuneTech · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NT-I7 | Administered by intramuscular (IM) injection. |
| DRUG | Nivolumab | Administered by intravenous (IV) injection. |
Timeline
- Start date
- 2021-01-21
- Primary completion
- 2023-05-26
- Completion
- 2023-05-26
- First posted
- 2020-10-20
- Last updated
- 2024-08-16
Locations
6 sites across 2 countries: United States, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04594811. Inclusion in this directory is not an endorsement.