Health Condition 1: X- New Technology
Conditions
Interventions
Intervention1: Naptumomab estafenatox (ABR-217620
NAP) with Durvalumab (MEDI4736): Naptumomab estafenatox (ABR-217620
NAP) was developed to activate and target the
patient T-cells to their own tumor, by fusing a superantigen (SAg) variant that activates
T lymphocytes, to the Fab moiety recognizing the tumor-associate
ABR-217620) is a recombinant fusion protein consisting of a chimeric
staphylococcal enterotoxin A/E (SEA/E) superantigen, with several substitutions, that is linked to an antigen-binding fragment (Fab
Sponsors
NeoTX Therapeutics Ltd
CliNovi Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: i. Group 1 no prior CPI: Subjects with only ESCC who may have received up to 1 prior chemotherapy as a line for metastatic disease or up to 2 prior chemotherapies if they also received neoadjuvant/adjuvant systemic therapy, but no prior CPI. a. If subjects received prior chemotherapy for metastatic disease, they should have documented radiographic or clinical progression. ii. Group 2 -prior CPI: a. Subjects with either ESCC or AC or GEJ (Siewert type 1) who must not have had more than 2 prior lines of therapy. Patients will be allowed to have up to 2 prior regimens for metastatic disease, or up to 3 prior therapies if they also received neoadjuvant/adjuvant systemic therapy. b. Subjects are eligible provided that they have received CPI therapy for at least 9 weeks, provided that they have documented progression of their disease on such therapy, and provided that prior CPI was not discontinued for toxicity. c. No more than 1 prior checkpoint inhibitor treatment is allowed (prior combination of anti-PD-(L) 1 and anti-CTLA-4 is acceptable). d. Subjects with adenocarcinoma that are HER-2/neu negative
Exclusion criteria
Exclusion criteria: Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF), myocardial infarction, or acute coronary syndrome within 6 months prior to study enrollment, ongoing angina pectoris, severe peripheral vascular disease, cerebrovascular accident (CVA) within 6 months of study entry, or any other concomitant medical disorder that might interfere with the subject’s participation in the study or interpretation of the study data. 8. Subjects who have undergone major surgery or trauma within 4 weeks of study entry. 9. Recent history of live attenuated vaccine within 28 days prior to obinutuzumab. NOTE: Patients, once enrolled, should not receive live vaccine whilst receiving study drug and up to 30 days after the last dose of study drug. 10. Known current drug or alcohol abuse. 11. Known active or latent tuberculosis (TB) infection (purified protein derivative [PPD] test is not required) as indicated by any of the following: PPD recently converted to positive; chest x-ray with evidence of infections infiltrate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. ORR by (iRECIST) of the combination of NAP with durvalumab in subjects with advanced/metastatic: a) squamous cell carcinoma of the esophagus without exposure to prior anti-PD-1/PD-L1 therapy, and b) squamous cell carcinoma or adenocarcinoma of the esophagus or the esophago-gastric junction, who have received prior anti-PD-1/PDL1 therapy.Timepoint: over the period of 24 months and 28 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess clinical activity in terms of overall survival (OS), progression-free survival (PFS), duration of response (DOR) and rate & duration of disease control in patients with CR, PR, or stable disease (SD), in each group. 2. To assess the safety & tolerability of the combination of NAP with durvalumab in subjects with advanced/metastatic carcinoma of the esophagus.Timepoint: 1. To assess clinical activity in terms of overall survival (OS), progression-free survival (PFS), duration of response (DOR) and rate & duration of disease control in patients with CR, PR, or stable disease (SD), in each group. | — |
Countries
India, Israel, United States of America
Contacts
Public ContactRadhika Inapakolla
CliNovi Research Pvt. Ltd.
Outcome results
None listed