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

NCT06493552 Phase 2/Phase 3 RECRUITING

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.

Details

Lead sponsor	Vasgene Therapeutics, Inc
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	700
Start date	2025-03-15
Completion	2034-08

Conditions

• Muscle-Invasive Bladder Carcinoma
• Metastatic Urothelial Carcinoma

Interventions

• SEphB4-HSA
• Pembrolizumab
• Gemcitabine
• Cisplatin
• Enfortumab vedotin

Primary outcomes

• Improved pathological response (pCR) in sEphB4-HSA+Pembro vs. Standard of Care for MIBC — Through study completion, an average of 6 months
  Pathologic complete response (pCR), a binary outcome. pCR is defined as absence of the muscle invasive component of the tumor in the radical cystectomy specimen by pathologic review. CIS (pTis), pT1, and pTa are considered to be pCR. All patients with pCR must have pN0/M0. Patients don't have pCR due to refusal of radical cystectomy, dropout prior to radical cystectomry, or pathologic evaluation results are inconclusive or unknown will be classified as non-responders in the ITT.
• Improved Overall Survival (OS) in sEphB4-HSA+Pembro vs. Standard of Care for MIBC — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
  Overall survival (OS) defined as period from randomization to death from any cause. OS will be censored at the last follow-up if patients are known to be alive. OS is a time to event variable of the primary interest.
• Improved Radiographic Objective Response Rate (ORR) in sEphB4+Pembro vs. Control in mUC — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
  Using RECIST 1.1 on CT or MR imaging of chest, MR imaging of Chest, Abdomen and Pelvis every 6 weeks for the first 3 months and then every 12 weeks.
• Non-inferior Overall Survival (OS) of sEphB4+Pembro vs. Control in mUC — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
  Overall survival (OS) defined as period from randomization to death from any cause. OS will be censored at the last follow-up if patients are known to be alive. OS is a time to event variable of the primary interest.

Countries

United States