drugset / Trial / NCT04594811
NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma
Non-randomizedSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-01-21
- Primary completion
- 2023-05-26
- Completion
- 2023-05-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NT-I7 | Protein / enzyme biologic | — | Intramuscular |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |