NCT03552796

sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer

A First-in-Human Phase I Study of Intravesical sEphB4-HSA in Patients With "BCG-Unresponsive" Bladder Carcinoma In Situ (CIS), Completely Resected High Grade Ta/T1, to Establish the Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein (sEphB4-HSA), and to see how well it works in treating participants with bladder cancer that has come back or that isn't responding to bacillus Calmette-Guerin (BCG) vaccine treatment. sEphB4-HAS prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. Giving sEphB4-HSA may work better in treating participants with bladder cancer.

Detailed description

PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) and recommended phase II dosing (RP2D) of intravesical sEphB4-HSA administration. II. To describe the dose limiting toxicities and adverse event profile of intravesical sEphB4-HSA administration in patients with bladder carcinoma in situ (CIS) and/or high grade T1/Ta bladder cancer (BCa). III. To describe the pharmacokinetics of intravesical sEphB4-HSA administration. IV. To explore the anti-tumor activity of intravesical sEphB4-HSA administration as manifested by responses to treatment. OUTLINE: This is a dose-escalation study. Participants receive sEphB4-HSA intravesically over 2 hours on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30 days, and again at 3 and 6 months.

Conditions

• Recurrent Bladder Carcinoma
• Bladder Cancer Stage 0
• Bladder Cancer Stage I

Interventions

Type	Name	Description
OTHER	Pharmacokinetic Study	Correlative studies
BIOLOGICAL	Recombinant EphB4-HSA Fusion Protein	Given intravesically

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-08-01
• Completion: 2025-08-01
• First posted: 2018-06-12
• Last updated: 2023-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study