A Modular, Open Label, Randomized Phase II/III Trial to Assess Efficacy of Combining sEphB4-HSA (EphrinB2 Inhibitor) With Immunotherapy Regimens in Patients With EphrinB2-High Solid Tumors
Vasgene Therapeutics, Inc
Summary
Patients with solid tumors that have high expression levels of EphrinB2 are treated with regimens that include EphrinB2 inhibitor, sEphB4-HSA. The primary objective of this study is to demonstrate additive therapeutic benefit for sEphB4-HSA. The secondary objectives are to determine whether the sEphB4-HSA containing regimen is safe and whether the oncological endpoints of importance in each cohort improve as a result of treatment with sEphB4-HSA containing regimen relative to a predefined threshold or to a control arm in the cohort where available. Treatment continues until progression of disease or unacceptable toxicities arise.
Description
The investigators hypothesize that the inhibition of EphrinB2 overcomes the negative prognostic impact of this biomarker and improves the treatment outcomes. It is further hypothesized that this higher level of activity is attributable to the synergistic immune-stimulatory effect of sEphB4-HSA when combined with pembrolizumab. Cohort A is designed to treat patients with MIBC whose tumors express EphrinB2. Patients in this cohort will be randomized to receive sEphB4-HSA + Pembrolizumab or Gemcitabine-Cisplatin (GC) regimen per standard of care of 4 cycle. Patients ineligible for cisplatin-base…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: General Inclusion Criteria for Both Arms * Willing and able to provide informed consent. * Men and women 18 years of age, or older. * Must provide the cell block or a minimum of 15 slides from the diagnostic biopsy or archival tissue. * Tumor tissue must be submitted for molecular profile through a commercial service such as Tempus, CARIS, Foundation One, etc. This must include a PD-L1 assay. * Tumor must express EphrinB2 as assessed by USC Norris Core Lab. * Zubrod performance status of less than or equal to 1. * Women of childbearing potential must use method(s) of cont…
Interventions
- DrugSEphB4-HSA
A recombinant protein comprised of the soluble form of human receptor EphB4 fused to human serum albumin.
- DrugPembrolizumab
Antibody to human PD-1.
- DrugGemcitabine
A chemotherapy drug used to treat various types of cancer.
- DrugCisplatin
A type of chemotherapy drug called an alkylating agent used to treat various types of cancer.
- DrugEnfortumab vedotin
Nectin-4-directed antibody and microtubule inhibitor conjugate.
Location
- Sarcoma Oncology CenterSanta Monica, California