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

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: NeoImmuneTech

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

Inclusion Criteria

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.

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.

+5 more

Exclusion Criteria

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.

You have used complementary medications (excluding herbal supplements or traditional Chinese medications) to treat the disease being studied within the past two weeks before starting the study treatment.

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Participant Groups

2Treatment groups

Experimental Treatment

Group I: Phase 2: NT-I7 and NivolumabExperimental Treatment2 Interventions

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).

Group II: Dose escalationExperimental Treatment2 Interventions

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).

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: