Gastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC)Phase 1NCT04594811
NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma
A Phase 1 study testing NT-I7 and Nivolumab in people with Gastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC), run by NeoImmuneTech at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC)
- What is being tested?
- NT-I7 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 21 Jan 2021to 26 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dose Escalation: Have histologically or cytologically confirmed locally advanced or metastatic solid tumor and can be either CPI-pretreated or CPI-naive.
- Phase 2: Have histologically or cytologically confirmed locally advanced or metastatic carcinoma of Gastric or Gastro-Esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC) and who progressed on or intolerant to 2 or more prior lines of standard therapy including chemotherapy, immunotherapy, and targeted therapy.
- Note: GEJ adenocarcinomas are defined as tumors that have their center within 5 cm proximal and distal of the anatomical cardia, as described in the Siewert classification system (Siewert et al, 2000).
- Have at least one measurable lesion according to RECIST 1.1.
- Participants enrolling in the dose escalation phase may have biopsiable disease. Optional for participants to provide a) pre-treatment tumor tissue sample and b) on-treatment tumor biopsy.
- At least 20 participants enrolled in the Phase 2 must agree to provide tumor tissue sample prior to the start of treatment.
- Female participants are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; if a female participant is of childbearing potential, she must agree to remain abstinent (refrain from heterosexual intercourse) or to follow instructions for one highly effective method of contraception for the duration of study treatment and for 5 months after the last dose of study treatment.
- Non-sterile male participants who are sexually active with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to follow instructions for one highly effective method of contraception for the duration of study treatment and for 3 months after the last dose of study treatment.
Who cannot join
- Pregnant, or breastfeeding or expecting to conceive or father children within the study duration from screening through 5 months (for female participants) or 3 months (for male participants) after the last dose of study treatment.
- Receiving chemotherapy or any anti-cancer therapy with half-life <1 week within 4 weeks or 5 half-lives, whichever is shorter, prior to first dose of study treatment.
- Has received prior radiotherapy within 2 weeks of start of study treatment.
- Has received treatment with complementary medications (excluding, herbal supplements, or traditional Chinese medications) to treat the disease under study within 2 weeks prior to the first dose of study treatment.
- Subjects are eligible if CNS metastases are asymptomatic and do not require immediate treatment or have been treated and subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
- History of severe hypersensitivity reactions to monoclonal antibodies (mAbs) or intravenous immunoglobulin preparation.
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- Clinically significant cardiac disease.
- Has a history of allergy or intolerance (unacceptable adverse events [AEs]) to study drug components or polysorbate-80-containing injections.
- Note: Polysorbate 80 is a buffer used to make NT-I7.
- Has received a live vaccine within 4 weeks prior to the first dose of study drug. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed.
- Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
- Subjects who were intolerable and discontinued from prior immune checkpoint inhibitors.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
The Center for Cancer & Blood Disorders
Fort Worth, Texas, 76104
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Poland2 sites
Centrum Medyczne Klara
Częstochowa, 42-202
Pratia Poznań
Skorzewo, 60-185
About this study
Official title: 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
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).
- Being tested
- NT-I7, Nivolumab
- Keywords
- NT-I7, Nivolumab, Dose escalation, Metastatic or Advanced
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-I7Drug
Also called Efineptakin alfa, rhIL-7-hyFc
Administered by intramuscular (IM) injection.
NivolumabDrug
Administered by intravenous (IV) injection.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | 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). Receives: Drug: NT-I7; Drug: Nivolumab |
| Phase 2: NT-I7 and Nivolumab | Experimental | 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). Receives: Drug: NT-I7; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Measured: 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
Measured: Up to 1 year
Dose escalation: Number of participants who experience one or more dose limiting toxicities (DLTs)
Measured: 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)
Measured: 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.
Measured: Up to 2 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Up to 3 years
Phase 2: Overall survival (OS)
OS is defined as the time from first study treatment to death from any cause.
Measured: Up to 2 years
Number of participants with anti-drug antibodies (ADA) to NT-I7
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start21 Jan 2021
- Primary completion26 May 2023
- Study completion26 May 2023
Why it stopped: Company strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoImmuneTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594811
- Sponsor's protocol ID
- NIT-109
- Other IDs
- 2020-004175-41
- Status last verified
- Apr 2024
- First submitted
- 14 Oct 2020
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04594811
- Acronym / sponsor ID
- NIT-109
- Keywords
- NT-I7, Nivolumab, Dose escalation, Metastatic or Advanced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company strategic decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NeoImmuneTechIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: NT-I7, Drug: NivolumabNT-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). |
| Phase 2: NT-I7 and Nivolumab | Experimental | Drug: NT-I7, Drug: NivolumabNT-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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Dose Escalation: Have histologically or cytologically confirmed locally advanced or metastatic solid tumor and can be either CPI-pretreated or CPI-naive.
- Phase 2: Have histologically or cytologically confirmed locally advanced or metastatic carcinoma of Gastric or Gastro-Esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC) and who progressed on or intolerant to 2 or more prior lines of standard therapy including chemotherapy, immunotherapy, and targeted therapy.
- Note: GEJ adenocarcinomas are defined as tumors that have their center within 5 cm proximal and distal of the anatomical cardia, as described in the Siewert classification system (Siewert et al, 2000).
- Have at least one measurable lesion according to RECIST 1.1.
- Participants enrolling in the dose escalation phase may have biopsiable disease. Optional for participants to provide a) pre-treatment tumor tissue sample and b) on-treatment tumor biopsy.
Key exclusion criteria (12 listed)
- Pregnant, or breastfeeding or expecting to conceive or father children within the study duration from screening through 5 months (for female participants) or 3 months (for male participants) after the last dose of study treatment.
- Receiving chemotherapy or any anti-cancer therapy with half-life <1 week within 4 weeks or 5 half-lives, whichever is shorter, prior to first dose of study treatment.
- Has received prior radiotherapy within 2 weeks of start of study treatment.
- Has received treatment with complementary medications (excluding, herbal supplements, or traditional Chinese medications) to treat the disease under study within 2 weeks prior to the first dose of study treatment.
- Subjects are eligible if CNS metastases are asymptomatic and do not require immediate treatment or have been treated and subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-I7Also: Efineptakin alfa, rhIL-7-hyFcAdministered by intramuscular (IM) injection. | Drug | Dose escalation, Phase 2: NT-I7 and Nivolumab |
| NivolumabAdministered by intravenous (IV) injection. | Drug | Dose escalation, Phase 2: NT-I7 and Nivolumab |
Primary outcome
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)
Time frame: Up to 2 years
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.
5 secondary outcomes
Duration of response (DoR)
Time frame: Up to 3 years
Disease control rate (DCR)
Time frame: Up to 3 years
Progression free survival (PFS)
Time frame: Up to 3 years
Phase 2: Overall survival (OS)
Time frame: Up to 2 years
Number of participants with anti-drug antibodies (ADA) to NT-I7
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: Company strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NT-I7 and Nivolumab in people with Gastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC), run by NeoImmuneTech at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company strategic decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation: Number of participants who experience one or more treatment-emergent adverse events (TEAEs) (time frame: Up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.