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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Administered by intramuscular (IM) injection.
Administered by intravenous (IV) injection.
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
The Center for Cancer & Blood Disorders
Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Centrum Medyczne Klara
Częstochowa, Poland
Pratia Poznań
Skorzewo, Poland
Dose escalation: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Time frame: Up to 1 year
Dose escalation: Number of participants who experience one or more common terminology criteria for adverse events (CTCAE) grade ≥ 3 adverse events
Time frame: Up to 1 year
Dose escalation: Number of participants who experience one or more dose limiting toxicities (DLTs)
Time frame: Up to 1 year
Dose escalation: Number of participants who experience one or more common terminology criteria for adverse events (CTCAE) grade ≥ 3 dose limiting toxicities (DLTs)
Time frame: Up to 1 year
Phase 2: Objective response rate (ORR)
ORR is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1.
Time frame: Up to 2 years
Duration of response (DoR)
DOR is defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1.
Time frame: Up to 3 years
Disease control rate (DCR)
DCR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD), per RECIST 1.1.
Time frame: Up to 3 years
Progression free survival (PFS)
PFS is defined as the time from the first study treatment to the first occurrence of disease progression or death of any cause, whichever occurs first, per RECIST 1.1.
Time frame: Up to 3 years
Phase 2: Overall survival (OS)
OS is defined as the time from first study treatment to death from any cause.
Time frame: Up to 2 years
Number of participants with anti-drug antibodies (ADA) to NT-I7
Time frame: Up to 3 years
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