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

• Status: Recruiting
• Trial end date: 2024-01-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeoImmuneTech
• Collaborator: Bristol-Myers Squibb
• Treatments: Nivolumab

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 3 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 3 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. 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).

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.