Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493552
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-25
Brief Title:
Modular Trial of SEphB4-HSA in EphrinB2-High Solid Tumors
Sponsor:
Vasgene Therapeutics Inc
Organization:
Vasgene Therapeutics Inc
Study Overview
Official Title:
A Modular Open Label Randomized Phase IIIII Trial to Assess Efficacy of Combining SEphB4-HSA EphrinB2 Inhibitor with Immunotherapy Regimens in Patients with EphrinB2-High Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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-based chemotherapy or refusing such chemotherapy will be able to receive pembrolizumab alone for 4 cycles based on PURE-01 data showing comparable response rate to chemotherapy with GC regimen
Cohort B will study the combination of sEphB4-HSA Pembrolizumab in previously treated mUC in EphrinB2-high subgroup a group that in previous studies demonstrated a 52 response rate In the multi-institutional retrospective series reported by the study team the expected response rate for anti-PD-L1PD-1 antibodies is 12 among tumors with high EphrinB2 expression This represents more than 4-fold improvement in efficacy of immunotherapy if EphrinB2 is inhibited with a mild toxicity profile for the combination In contrast EV Pembrolizumab while effective has a significant and at times prohibitive toxicity profile It is also unclear whether EV Pembrolizumab can deliver the published results in patients with high EphrinB2 expression Therefore Cohort B is designed to explore this question
Upon study entry participants in either Cohort will be randomly assigned to either sEphB4-HSA Pembrolizumab or Standard of Care Control Study interventions will be administered according to the protocol and participants will be monitored and assessed for safety and efficacy at designated times throughout the study
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-based chemotherapy or refusing such chemotherapy will be able to receive pembrolizumab alone for 4 cycles based on PURE-01 data showing comparable response rate to chemotherapy with GC regimen
Cohort B will study the combination of sEphB4-HSA Pembrolizumab in previously treated mUC in EphrinB2-high subgroup a group that in previous studies demonstrated a 52 response rate In the multi-institutional retrospective series reported by the study team the expected response rate for anti-PD-L1PD-1 antibodies is 12 among tumors with high EphrinB2 expression This represents more than 4-fold improvement in efficacy of immunotherapy if EphrinB2 is inhibited with a mild toxicity profile for the combination In contrast EV Pembrolizumab while effective has a significant and at times prohibitive toxicity profile It is also unclear whether EV Pembrolizumab can deliver the published results in patients with high EphrinB2 expression Therefore Cohort B is designed to explore this question
Upon study entry participants in either Cohort will be randomly assigned to either sEphB4-HSA Pembrolizumab or Standard of Care Control Study interventions will be administered according to the protocol and participants will be monitored and assessed for safety and efficacy at designated times throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None