A Multicenter, Open-label, Phase 2 Study of NT-I7 in Combination with Nivolumab in Subjects with Advanced or Metastatic Stomach, Esophageal Cancers who Progressed on or Were Intolerant to 2 or More Previous Therapies
- Conditions
- Relapsed/refractory gastric or gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC) progressed on or intolerant to 2 or more prior lines of systemic therapyMedDRA version: 22.0Level: LLTClassification code 10082464Term: Advanced gastric carcinomaSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10058526Term: Oesophageal adenocarcinoma metastaticSystem Organ Class: 100000004864MedDRA version: 23.1Level: LLTClassification code 10084873Term: Gastrooesophageal junction cancer metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-004175-41-PL
- Lead Sponsor
- eoImmuneTech, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 68
Key Inclusion Criteria
1.Subjects enrolling in the dose escalation phase must have histologically or cytologically confirmed locally advanced or metastatic solid tumor and can be either CPI-pretreated or CPI-naive.
2.For the Phase 2, 1) subjects must have histologically or cytologically confirmed locally advanced or metastatic carcinoma of gastric or GEJ or EAC and 2) have progressed on 2 or more prior lines of standard therapy including chemotherapy, immunotherapy and targeted therapy. Note: Confirmation radiographic progression on prior therapy is required at least 4 weeks from the initial disease progression. Screening scans can be used as the confirmation of progression. Progression following target therapy, or other approved or investigational therapies is allowed. 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)
3.Have at least one measurable lesion according to RECIST 1.1.
4.Subjects enrolling in the dose escalation phase may have biopsiable disease. It is optional for subjects to provide a) pre-treatment tumor tissue sample and b) on-treatment tumor biopsy.
5.In the Phase 2 at least 20 subjects are required to provide tumor tissue sample. These subjects must have biopsiable disease (i.e. at least 1 tumor lesion that is accessible and feasible for biopsy) as determined by the investigator. These 20 subjects must agree to provide a) pre-treatment tumor tissue sample and b) on-treatment tumor biopsy. Fresh tumor biopsies are preferred.
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 68
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 7 months (for male subjects) after the last dose of study treatment.
2.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.
3.Has received prior radiotherapy within 2 weeks of start of study treatment.
4.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.
5.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).
6.Subjects who have not recovered from AE due to agents administered >4 weeks earlier (i.e., have residual toxicities > Grade 1).
7. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
8.History of severe hypersensitivity reactions to monoclonal antibodies (mAbs) or intravenous immunoglobulin preparation. Any history of anaphylaxis.
9.Subject who have spinal cord compression not definitively treated with surgery and/or radiation.
10.Subject who have an active, known or suspected auto-immune disease
11.Have active and clinically relevant bacterial, fungal, viral or tuberculosis infection
12.Clinically significant cardiac disease.
13.Subjects who have received treatment with systemic immunosuppressive medications within 1 week prior to the first dose of study treatment.
14.History of allergy or intolerance (unacceptable AEs) to study drug components or polysorbate-80-containing injection. Note: Polysorbate 80 is a buffer used to make NT-I7.
15.History of non-infectious pneumonitis.
16.Has received a live/attenuated 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.
17.Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
18.Receiving monoclonal antibodies (mAbs), and/or mAb-derived therapies within 4 weeks prior to first dose of study treatment.
19.Subjects who were intolerable and discontinued from prior immune checkpoint inhibitors.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method