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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NT-I7 — DRUG
  Administered by intramuscular (IM) injection.
• Nivolumab — DRUG
  Administered by intravenous (IV) injection.

Study Details

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).

Key Dates

Start date

Jan 21, 2021

Status verified

Apr 2024

Primary completion

May 26, 2023

Completion

May 26, 2023

Study Design

Enrollment

10 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dose escalation
  NT-I7 will be administered on Day 1 of alternate 4 weeks cycles (Cycle 1, 3, 5 etc.) (Q8W). Dosage will increase until the maximum tolerated dose (MTD) and/or the recommended phase 2 (RP2D) dose is reached. Nivolumab will be administered on Day 1 of every 4 week cycle (Q4W).
• Experimental: Phase 2: NT-I7 and Nivolumab
  NT-I7 will be administered on Day 1 of alternate 4 weeks cycles (Cycle 1, 3, 5 etc.) (Q8W) at the recommended phase 2 dose (RP2D) identified during Dose escalation phase. Nivolumab will be administered on Day 1 of every 4 week cycle (Q4W).

Primary Outcome Measure

Dose escalation: Number of participants who experience one or more treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 1 year ]

Locations (4)

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