A Multicenter, Open-label, Randomized, Phase 2 Study of NT-I7 in Combination with Nivolumab versus Nivolumab Alone in Subjects with Advanced or Metastatic Stomach, Esophageal Cancers who Progressed on or Were Intolerant to 2 or More Previous Therapies

Phase 1

• Conditions: Advanced or metastatic gastric or gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC) progressed on or intolerant to 2 or more prior lines of systemic therapy; MedDRA version: 21.0Level: LLTClassification code 10058526Term: Oesophageal adenocarcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10030145Term: Oesophageal adenocarcinoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004175-41-IT
• Lead Sponsor: eoImmuneTech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

Key Inclusion Criteria
1. Have histologically or cytologically confirmed locally locally advanced or metastatic carcinoma of gastric or GEJ or EAC who progressed on or intolerant to 2 or more prior lines of chemotherapy and/or targeted therapy in the advanced/metastatic setting. Subjects 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. Subjects enrolling in the dose escalation phase must have biopsiable disease. Subjects must agree to provide a) pre- treatment tumor tissue sample and b) on-treatment tumor biopsy.
4. Subjects 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 subjects enrolled in Phase 2.
6. Female subjects are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; if a female subject 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 subjects 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 107
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Key Exclusion Criteria
1. Pregnant, or breastfeeding or expecting to conceive or father children within the study duration from screening through 5 months (for female subjects) or 3 months (for male subjects) 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 (ex, 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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified