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: 21.0 Level: LLT Classification code 10058526 Term: Oesophageal adenocarcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 22.0 Level: LLT Classification code 10082464 Term: Advanced gastric carcinoma System Organ Class: 10029
Conditions
Interventions
Product Name: NT-I7
Product Code: NT-I7
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Efineptakin alfa
Current Sponsor code: NT-I7
Other descriptive name: rhIL-7-hyFc
Concentration
Sponsors
NeoImmuneTech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To make a preliminary assessment of the antitumor activity and long-term survival of NT-I7 in combination with nivolumab in subjects with advanced or metastatic gastric or GEJ or EAC after 2 or more prior lines of systemic therapy, based on: o Objective response rate (ORR) per Investigators’ assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 o Overall survival (OS);Secondary Objective: To make further assessment of the antitumor activity of NT-I7 in combination with nivolumab in the treated subjects, based on Duration of Response (DoR), Disease Control Rate (DCR), and Progression-Free Survival (PFS); To evaluate the immunogenicity of NT-I7 administered in combination with nivolumab.;Primary end point(s): Overall survival (OS) and objective response rate (ORR) assessed by the investigators using RECIST 1.1 criteria are the primary endpoints for Phase 2. OS is defined as the time from first study treatment to death from any cause. 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.;Timepoint(s) of evaluation of this end point: Up to 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of response (DoR), disease control rate (DCR), progression-free survival (PFS) and Incidence of anti-drug antibodies (ADA) to NT-I7 during the study relative to baseline are the secondary endpoints for Phase 2. 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. 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. 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.;Timepoint(s) of evaluation of this end point: Up to 3 years. | — |
Countries
France, Italy, Poland, Spain, United States
Contacts
Public ContactClinical Division
NeoImmuneTech, Inc.
Outcome results
None listed