Clinical Trials /

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

NCT04594811

Description:

The main purposes of Phase 1 (dose escalation) 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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma
  • Official Title: A Multicenter, Open-label, Randomized, Phase 2 Study of NT-I7 in Combination With Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced or Metastatic Gastric or Gastro-Esophageal Junction or Esophageal Adenocarcinoma Who Progressed on or Intolerant to 2 or More Prior Lines of Systemic Therapy

Clinical Trial IDs

  • ORG STUDY ID: NIT-109
  • SECONDARY ID: 2020-004175-41
  • NCT ID: NCT04594811

Conditions

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

Interventions

DrugSynonymsArms
NT-17Efineptakin alfa, rhIL-7-hyFcPhase 1: Dose escalation
NivolumabPhase 1: Dose escalation

Purpose

The main purposes of Phase 1 (dose escalation) 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.

Trial Arms

NameTypeDescriptionInterventions
Phase 1: Dose escalationExperimentalNT-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 cycles (Q4W).
  • NT-17
  • Nivolumab
Phase 2: NT-17 and NivolumabExperimentalNT-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 cycles (Q4W).
  • NT-17
  • Nivolumab
Phase 2: Nivolumab AloneActive ComparatorNivolumab will be administered on Day 1 of every 4 week cycles (Q4W).
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          1. Have histologically or cytologically confirmed locally locally advanced or metastatic
             carcinoma of Gastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma
             (EAC) who progressed on or intolerant to 2 or more prior lines of chemotherapy and/or
             targeted therapy in the advanced/metastatic setting. Participants with
             HER2-overexpresing tumor who progressed on trastuzumab-based therapy and at least 1
             other line of therapy are also eligible.

             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)

          2. Have at least one measurable lesion according to RECIST 1.1.

          3. Participants enrolling in the dose escalation phase must have biopsiable disease.
             Participants must agree to provide a) pre- treatment tumor tissue sample and b)
             on-treatment tumor biopsy.

          4. Participants enrolled in the Phase 2 must agree to provide tumor tissue sample prior
             to the start of treatment.

          5. PD-L1 expression status must be determined by the study-designated central lab prior
             to randomization (CPS <5 versus CPS ≥ 5) for participants enrolled in Phase 2.

          6. 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.

          7. 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 7 months after the last dose
             of study treatment.

        Exclusion Criteria:

          1. Pregnant, or breastfeeding or expecting to conceive or father children within the
             study duration from screening through 5 months (for female participants) or 7 months
             (for male participants) after the last dose of study treatment.

          2. Receiving any investigational therapy or any approved therapy for investigational use
             within 4 weeks or 5 half-lives, whichever is longer, prior to first dose of study
             treatment.

          3. Has previously received checkpoint inhibitor (CPI) treatment for gastric cancer or GEJ
             or EAC.

          4. Has received prior radiotherapy within 2 weeks of start of study treatment.

          5. 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.

          6. Has known active central nervous system (CNS) metastases and/or carcinomatous
             meningitis. Participants with previously treated brain metastases may participate
             provided they are radiologically stable.

          7. History of severe hypersensitivity reactions to monoclonal antibodies (mAbs) or
             intravenous immunoglobulin preparation.

          8. Clinically significant cardiac disease.

          9. Has a history of allergy or intolerance (unacceptable adverse events [AEs]) to study
             drug components or polysorbate-80-containing infusions.

             Note: Polysorbate 80 is a buffer used to make NT-I7.

         10. 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.

         11. Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1 (dose escalation) only: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Time Frame:Up to 1 year
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Duration of response (DoR)
Time Frame:Up to 3 years
Safety Issue:
Description: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.
Measure:Disease control rate (DCR)
Time Frame:Up to 3 years
Safety Issue:
Description: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.
Measure:Progression free survival (PFS)
Time Frame:Up to 3 years
Safety Issue:
Description: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.
Measure:Number of participants with anti-drug antibodies (ADA) to NT-17
Time Frame:Up to 3 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:NeoImmuneTech

Trial Keywords

  • NT-17
  • Nivolumab
  • Dose escalation
  • Phase 2
  • Metastatic or Advanced

Last Updated

October 14, 2020